Job Description

We are actively seeking for a knowledgeable, proactive and dedicated professional to guide and lead our Clinical Operations team in Türkiye through its next phase of growth in the dynamic and fast-paced clinical trials environment. In this role, you will have the unique opportunity to utilize your vision and passion for fostering development and drive to excellence the local operational presence.

Based in Türkiye

The scope of responsibilities will include:

• Line management of Clinical Operations staff
• Management of multiple aspects of clinical research from business development to project execution
• Coordination of resource allocation to projects
• Oversight of the staff workload, performance appraisal and career advancement
• Training, coaching and mentoring the team
• Hiring, onboarding and integrating new Clinical Operations’ employees
• Ensuring compliance with GCP standards and internal/external procedures
• Development and implementation of quality control
• Regional project oversight
• Management of the budgets on the country level
• Maintenance, revision and establishment of processes on the regional level
• Ensuring smooth operations of the company in Türkiye, providing full managerial and administrative support to all staff in the country
• Communication point to investigators, regulatory and ethics authorities, clients and vendors for various project-related matters

Qualifications

• College or University degree in Life Sciences
• Demonstrated operations experience in a CRO (preferable), or a pharma company including knowledge of project startup, monitoring, site management, project administration, and other relevant Clinical Operations´ processes
• Experience with clinical research sites, R+D processes, legal, regulatory and ethics in Türkiye
• Bid defense experience is preferable
• At least 2 years’ experience in clinical team management with strong people management skills
• Experience in management of remote teams
• Basic financial knowledge and demonstrated ability to manage budgets
• Excellent communication in English and Turkish
• Proficiency in standard MS Office applications
• Ability to travel internationally
• Strong time management, organizational, leadership, planning and presentation skills, result-oriented approach

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Job Description

• Identify areas and processes within PSI where the use of AI/ML will lead to process improvement, driving efficiency, productivity, and quality.
• Lead end-to-end AI/ML projects / initiatives, including ideation, planning, testing, deployment, and monitoring.
• Establish and monitor the metrics allows for evaluation of the value generated through AI/ML projects / solutions.
• Adheres and implement AI governance frameworks, including policies, standards, and best practices.
• Support governance by conducting risk assessments and identify potential ethical, legal, and reputational risks associated with AI use.
• Familiar with AI regulations and compliance requirements
• Collaborate with internal stakeholders (e.g. engineers, data scientists, product managers) to integrate AI governance principles into project development and deployment.
• Conduct training and workshops to educate employees on AI best practices.
• Monitor and audit compliance with AI policies and procedures.
• Support to develop and implement metrics to track and measure the effectiveness of AI governance initiatives.
• Communicate complex AI governance issues clearly and concisely to both technical and non-technical stakeholders.

Qualifications

Educational Background:

• Bachelor’s degree in computer science, AI, Business Administration, or related field, or a combination of education and related work experience.

Experience:

• 3-5 years of experience in AI(ML/DL/NLP/LLM) and technology solution implementation
• Proven experience in AI governance, ethics, compliance, or related fields.
• Proven experience in developing and implementing policy frameworks, particularly in technology or data protection.
• Experience with regulatory compliance and risk management.
• Deep knowledge of AI systems, their use cases and risks/impacts of AI to organizations (healthcare and life science).

Training & Skills:

• Project management, communication, and collaboration skills.
• Analytical and problem-solving skills, with ability to identify and mitigate risks.

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Job Description

Full-time employment in Lithuania

As a Full stack Developer you will be involved in development of projects for internal clients and will provide quality coding to support PSI business processes and operations. 

You will:

• Architect, develop and maintain business applications
• Process user requests for developing of new and support for existing IT systems
• Prepare documentation related to development and maintenance of business applications
• Execute and implement software tests, participate in code reviews
• Follow the development standards applied within the department
• Track the development, maintenance and related tasks in the tracking system used within the team
• Follow the progress of systems development technologies and advance professional skills as necessary

Qualifications

The ideal candidate will have:

• Knowledge of building web-based applications
• Knowledge of web technologies including JS(ES+), Typescript, HTML5, CSS, Webpack
• Knowledge of C# language, Microsoft .NET frameworks, Blazor, technologies and best practices
• Knowledge of unit-testing, knowledge of other testing methods is a plus
• Knowledge of Transact SQL, MS SQL functions, stored procedures and other SQL objects
• Familiarity with software analysis, testing and debugging code
• Ability to write high-quality, efficient and easily testable code
• Team-oriented, deadline-driven, with good communication skills
• BSc/BA in computer science, software engineering or relevant discipline
• Full working proficiency in English

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Job Description

• Writes, edits, and reviews Essential Documents, including informed consent forms, patient information, and other project-specific clinical documentation
• Writes, edits, reviews, finalizes, and tracks clinical study report (CSR) patient safety narratives
• Collects and tracks documents for CSR appendices, in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing
• Critically assesses, interprets, and summarizes data from clinical studies
• Reviews scientific literature pertinent to medical writing activities
• Performs quality control (QC) reviews of PSI-developed Essential Documents and other documentation (in support of the Quality Control Associates and if assigned by the Associate Director, Medical Writing)
• Acts as a backup contact for the Project Managers and other PSI functional areas within the scope of assigned medical writing tasks
• Collaborates with the Process Improvement narrative automation team to develop patient safety narratives

Qualifications

• College or university degree, preferably a Bachelor’s/Master’s degree in biomedical or life sciences fields, or a relevant combination of education, training, and experience that presents the required knowledge, skills, and abilities.
• Minimum 2 years of corresponding industry experience working with clinical documentation and data
• Prior pharmaceutical, biotechnology, or contract research organization experience
• Basic knowledge of global regulations and guidelines (FDA, ICH) on the drug development process and on production and publishing of Essential Documents
• Basic knowledge of electronic Common Technical Document (eCTD) requirements

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Job Description

PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.

Responsibilities:

• Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
• Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
• Address safety issues across the study from sites and the study team
• Review listings for coded events to verify Medical Dictionary for Regulatory activities
• Participate in bid defense meetings
• Assist in Pharmacovigilance activities
• Identify Program risks, and create and implement mitigation strategies with Clinical Operations
• Ability to organize and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
• Review and sign off clinical documents with respect to medical relevance.

Qualifications

• Medical Doctor degree
• Internal Medicine certification is a must
• Prior and wide experience in medical practice/patient care (minimum of 10 years)
• Prior experience working with clinical trials is a plus
• Prior experience with ICU is a plus
• Full working proficiency in English and Spanish
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented

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Job Description

We are currently looking for a knowledgeable and proactive MS SQL Database Developer to join our Systems Development Team.

Full-time employment in Latvia

You will:

• Develop and maintain information systems based on MS SQL
• Process user requests for developing new IT systems and supporting existing ones
• Develop and maintain documentation related to database structure, database objects and instructions thereof
• Develop, implement and maintain automated and manual processes for database backup and related operations
• Track the development, maintenance and related tasks in the internal tracking system
• Participate in design, development and implementation of database systems based on user requirements
• Extract, transform, load data from various sources
• Develop security procedures to protect databases from unauthorized access
• Optimize database systems for performance and efficiency

Qualifications

• Bachelor's degree in IT or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities
• 2 years’ experience as a Database Developer or similar position
• Database administration experience
• Experience in software development is a plus
• Full working proficiency in English
• Experience in generating complex data queries using Transact SQL
• Experience in developing MS SQL functions, stored procedures, and other SQL objects
• Experience in database design and architecting process is a plus

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Job Description

As a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry. We are committed to develop our employees in their careers by providing tailored courses and mentoring. 

You will:

• Conduct and report all types of onsite monitoring visits
• Be involved in study startup and feasibility research
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• Support regulatory team in preparing documents for study submissions

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Independent on-site monitoring experience Mexico
• Experience in all types of monitoring visits in Phase II / III
• Full working proficiency in English and Spanish
• Proficiency in MS Office applications
• Ability to plan and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills
• Ability to travel

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Job Description

The scope of responsibilities will include

Start-up Responsibilities:

• Is involved with in-house and on-site activities related to site identification and new clinical trial placement.

• Is involved in setting clinical trials related collaboration with medical professionals.

• Ensures comprehensive internal handovers from Feasibility to Operations.

• Defines the optimal site profile for a study and recommends the best, high-quality sites after contacting and evaluating their capabilities and potential for study conduct.

• Reviews therapeutic indication, and study specific materials prior to contacting sites.

• Creates and/or maintains a site identification tracker.

• Regularly communicates with Project Teams to update them on the status/progress of the site ID, as well as highlights any potential risks or issues to timelines or objectives.

Ongoing Project Responsibilities (all phases):

• Creates and maintains a therapeutic area-specific site database.

• Assists Project Teams during the enrollment phase by identifying additional sites when necessary.

• Develops strategies to accelerate site identification through the use of external databases like Citeline and CenterWatch, contacting SMOs, site networks, advocacy and support groups and central IRBs etc.

• Training: Trains CTAs and CRAs on how to get the best information from sites, acts as a trainer and mentor.

• Business Development and Corporate assignments: Participates in the preparation of presentations for client and bid defense meetings, provides input in various regulatory aspects (as requested).

Qualifications

Qualifications

• Life sciences degree (proven CRA experience is a plus)

• Experience of working in practical healthcare settings (hospital, outpatient clinic) is a strong plus.

• Prior experience in Site Identification/Study Start-Up activities is a strong plus.

• Practical experience in clinical trials related activities (study coordinator, sub-investigator) is a strong plus.

• Excellent written and oral communication skills, as well as time management skills

• Demonstrates the ability to multitask under compressed deadlines across several projects, each with unique requirements

• Advanced English and native Italian

You are dynamic. You are curious. You are more than your job. For you, excellence isn’t just a word; it’s the measure for all you do. You’re passionate. Driven. Dedicated. You can’t stand mediocrity. And you might be the team member we're looking for.

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Job Description

PSI Medical Monitors provide medical input to global clinical studies and advise the teams and business partners, while always focusing on patients' safety and well-being.

Home-Based in the United States

Responsibilities:

• Advise clients, project teams, sites, data safety monitoring boards, regulatory agencies and third-party vendors on medical matters
• Collaborate with internal departments in the preparation of clinical development plans, protocols, investigator brochures, annual reports, clinical study reports, manuscripts, and different scientific presentations
• Review and analysis of clinical data to ensure the safety of study participants in clinical studies
• Ensure that the reported data is accurate, complete, and verifiable, and that the conduct of the trial is in compliance with the currently approved protocol/amendments
• Address safety issues across the study from sites and the study team
• Review listings for coded events to verify Medical Dictionary for Regulatory activities
• Participate in bid defense meetings
• Assist in Pharmacovigilance activities
• Identify Program risks, and create and implement mitigation strategies with Clinical Operations
• Ability to organize and lead clinical development advisory boards and safety monitoring boards
• Ensure Study team compliance with FDA, EMEA, ICH and GCP guidelines
• Review and sign off clinical documents with respect to medical relevance.

Qualifications

• Medical Doctor degree required
• US Board Certification in Nephrology required
• Experience as a practicing Nephrology (minimum of 10 years)
• Full working proficiency in English
• Clinical Research experience preferred
• Proficiency with MS Office applications
• Communication, presentation and analytical skills
• Problem-solving, team and detail-oriented

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Job Description

This position is open to those based in the San Francisco Bay Area. 

In this position, you will, 

• Actively prospect and leverage potential new business opportunities within specified Customer/Accounts.
• Cultivate strong, long-term relationships with key decision-makers within the Account and develop deep knowledge of the Customer/Account organization.
• Analyze potential opportunities and develop detailed business plans and sales strategies for each Customer/Account. 
• Identify and respond to Customer/Account needs in order to define potential PSI opportunities.  Ensure appropriate strategy/solution is proposed to Customer/Account.
• Work with Operations to identify sales team and prepare presentation.  Educate team participants in Customer/Account culture, operational needs/methods and sales techniques needed to close the sale.
• Lead the entire sales process, including identifying the appropriate team for pitch and preparing and leading the sales presentation.
• Coordinate with the Proposal Development Group to develop proposal and Operations to finalize strategy and pricing.
• Handle follow-up related to the sales and facilitate completion of contractual documents.
• Ensure appropriate hand-off to project team by transferring knowledge on Customer/Account needs and expectations.
• Share Customer/Account strategies and sales plans with Project Directors/Managers.
• Coordinate with Project Managers/Directors and Operations to escalate and quickly address Customer/Account issues/concerns.
• Seek input from Project Managers/Directors to proactively address Change in Scope, new opportunities or customer dissatisfaction.
• Work with Project Manager/Director and Operations to ensure Changes in Scope (CIS’s) are appropriately negotiated with the Customer/Account.
• Maintain high visibility within Customer/Account organization.
• Monitor Customer satisfaction through regular formal and informal surveys.
• Coordinate with Project Managers/Directors to ensure Customer/Account needs are being met and address concerns/issues in a timely manner.
• Review proposals and analyzes requests for proposals and protocols.
• Attend industry events, set up meetings at events, and perform follow-up with potential clients.
• Act as a liaison between Bay Area clients and Operations on an as needed basis.

Salary Range: $100K - $500K 

Qualifications

• University degree in health sciences or an equivalent combination of education, training & experience.
• Demonstrable competency in sales or business development preferably for a Contract Research Organization or company providing services to the healthcare industry.
• 3 - 5 years of business development experience in the CRO sales arena.
• Working proficiency with Salesforce.
• Strong communication, collaboration, problem solving, and time management skills.
• Capable and willing to travel.

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Job Description

• Coordinates investigator/ site feasibility and identification process, as well as study startup.
• Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.
• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.
• Manages Monitors in the query resolution process, including Central Monitoring observations.
• Coordinates safety information flow and protocol/process deviation reporting.
• Performs clinical supplies management with vendors on a country and regional level.
• Ensures study-specific and corporate tracking systems are updated in a timely manner.
• Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.
• Coordinates planning of supervised monitoring visits and conducts the visits. 
• Manages the project team in site contracting and payments.
• Leads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.
• Ensures ongoing evaluation of data integrity and compliance at a country/regional level.
• Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.
• Oversees project team in CAPA development and implementation.
• Coordinates project team in process deviations review, management and reporting.
• Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.
• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.
• Delivers trainings and presentations at Investigator Meetings.
• Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.
• Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.
• Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.
• Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.
• Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.
• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.
• Ensures data integrity and compliance at a site level.
• Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.
• Conducts project-specific training of site Investigators.
• Supports preparation of draft regulatory and ethics committee submission packages.

Qualifications

• Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.
• Minimum of 5 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor. 
• Experience with all types of monitoring visits in Phase II and/or III.
• Strong experience in Oncology preferred.
• Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. 
• Full working proficiency in English.
• Proficiency in MS Office applications.
• Ability to plan, multitask and work in a dynamic team environment.
• Excellent Communication, collaboration, and problem-solving skills.
• Ability to travel up to 65% (depending on project needs).
• Valid driver’s license (if applicable).

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Job Description

The Global Marketing Manager - Europe will help lead the marketing vision, strategy, and development for PSI CRO, championing the brand through digital, traditional, and experiential efforts. They will help connect sales efforts with digital intelligence, collaborate on employment branding, and help direct new efforts toward communicating our company’s unique culture and narrative across the globe.

This dynamic role will report directly to the Senior Director of Global Marketing and be a part of regional and some global Marketing elements within the department: internal, external, sales, and client-facing work. A fast-paced position, it requires excellent interpersonal skills, the ability to think on your feet, and a deep well of new ideas. This rapidly growing team functions as an agency within the company, and has both internal and external clients, so it’s essential that the right fit is comfortable wearing many hats but simultaneously understands both their own values and the company’s culture.

Remote-based in France

RESPONSIBILITIES

• Oversee global account-based marketing and strategy
• Work closely with Business Development on sales support initiatives in Europe
• Manage and maintain PR contacts in industry/paid advertisements/placements in Europe
• Help develop content marketing strategy in support of sales and marketing
• Prioritize engagement with key audiences – KOLs, patients, prospective clients, clients
• Ensure industry and GDPR compliance across all digital channels with web development
• Maintain high attention to detail to ensure accuracy and consistency among all content
• Perform market research (both real-time and traditional) on a regular basis in region and globally

Qualifications

• Bachelor’s degree in communication, journalism, PR, marketing, or related field
• Experience in CRO Marketing and other regulated industry like finance, education, etc.
• Digital management experience
• Experience in a global or cross-regional role
• Effective third-party vendor management experience or experience working in an agency
• Event planning experience is a plus
• Branding experience is a plus
• Strong writing and editing experience, outstanding verbal communication skills
• Executive presence and ability to deliver presentations in small and large groups at all organizational levels
• Capable of managing multiple projects at once with high attention to detail
• Strategic and knowledgeable about digital marketing, advertising regulations within different countries
• Comfortable in a dynamic, fast-paced environment
• Proficient in English

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Job Description

The Lead Data Manager will be responsible for all data management activities in large, complex studies under general supervision, or working under minimal supervision on data management activities for small to medium sized projects. 

 Communication

• Primary communication point for project teams and company departments with regard to clinical data management
• Communication line for clients/vendors for all data management aspects of clinical projects and clinical data management reporting

 Data Management

• Coordination of data management activities within clinical projects related to EDC development, data collection, cleaning, reconciliation, Database Lock, development of final integrated database and generation of final Data Management deliverables. 
• Primary responsibility for clinical data management activities within clinical projects, including, but not limited to:
  • Study documents review
  • Data Management plan and other project-specific guidelines and instructions development and review
  • Co-ordinate/perform user acceptance testing
  • Development of Data Validation Plan/Edit Check Specifications
  • Data entry coordination and supervision, feedback to data entry personnel regarding quality of data entry and other data entry issues
  • Data validation, including automatic and manual data inspections, data discrepancies/deficiencies review and resolution, query generation and resolution, feedback to clinical trial teams regarding quality of data
  • Non-CRF electronic data handling (receiving, archiving, loading into study database, review and resolution of reconciliation issues, feedback to vendors regarding quality of data and other issues)
  • Database edits (paper CRF studies)
  • Manual CRF review (non-medical checks)
  • Clinical database lock
  • Coordination and supervision of processing, dispatch and archiving of CRFs/queries
• Input into design of CRFs and other data collection forms; review Case Report Form design for accuracy and adherence to protocol
• Development of CRF completion guidelines
• Coding medical data with coding dictionaries and coding listings review (Lead DMs with medical/biology background, additional training required)
• SAE reconciliation
•  Electronic data transfer (import/export) specifications review and approval

Document Management

• Liaison with Document Center with regard to maintenance of TMF and eTMF

Quality Control

• Database QC checks performance and documentation
• Shared responsibility for preparation and attendance at internal and client/third-party audits/inspections of Data Management
• Shared responsibility for follow-up on and resolution of audit findings pertaining to Data Management

Training

• Training of Assistant Data Managers
• Project-specific training of investigators and clinical team in CRF completion

Corporate/Departmental Assignments

• Investigator Meetings preparation/attendance
• Meetings and teleconferences organized by client/vendor preparation/attendance

Qualifications

• College or University degree or equivalent combination of training and experience that presents the required knowledge, skills and abilities
• At least 3 years of experience of full scope of data management responsibilities in international EDC studies
• At least 2 years of experience using CDM/EDC systems (Medidata Rave or Oracle Inform preferable)
• Project data management experience is a plus
• Full working proficiency in English
• Organizational and managerial skills

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Job Description

Please submit your CV in English

You will contribute to statistical programming activities related to global clinical trials, work closely with international teams of statisticians, programmers and data managers, program data sets and summaries.

You will:

• Develop analysis data sets structure
• Develop program requirements and specifications
• Be involved in SAS programming of ADS and Tables, Listings and Figures
• Support SAS program validations
• Prepare and review  program documentation
• Produce TFL
• Communicate with project teams and company departments with regard to statistical programming of clinical research projects

Qualifications

• University and master's degree in applied science, mathematics, statistics or the like
• Knowledge of SAS software (SAS BASE/SAS STAT/SAS GRAPH) and experience of work in SAS system
• Good knowledge of programming logic, SQL and macro programming is preferred
• Proficient in English, spoken and written
• Experience within clinical trials and/or Biostatistics
• Good analytical skills
• Proficiency in standard MS Office applications
• Excellent communication and interpersonal skills

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Job Description

Resource Management and Training:

• Participation in QM resource allocation
• Resource allocation of QA auditors
• Facilitation of professional development and career advancement of Quality Management staff
• Administrative supervision of Quality Management staff, jointly with Senior Director Quality Management
• Participation in recruitment of Quality Management (QM) staff
• Facilitation of initial and ongoing training of Quality Management staff
• Oversight of initial and ongoing training of PSI Operations employees in quality management topics

Quality Management:

• Facilitation of regulatory agency inspections of PSI
• Facilitation of regulatory agency inspections of PSI-managed trial sites, including follow-up
• Participation in hosting client/third party audits of PSI, including follow-up
• Oversight of CAPA investigations management
• Management of investigations of suspected research misconduct, jointly with Senior Director Quality Management
• Backup responsibility for review of draft Quality Systems Documents (QSDs), including newly developed and revised QSDs
• Backup responsibility for approval of Quality Systems Documents
• Oversight of vendor qualification
• Oversight of computer systems validation documentation review
• Oversight of the process of providing assistance and feedback to all Company staff with regards to various GXP, regulatory compliance, and other QM matters
• May act as the primary QM contact for PSI Operations divisions and working groups/task forces with regard to various Corporate projects requiring QM

Quality Assurance Auditing:

• Development and implementation of the annual audit plan
• Management of QA audits contracted to PSI
• Oversight of the preparation and maintenance of internal and contracted quality assurance audits documentation

Business Development:

• May be recruited by Business Development for client meetings and vendor shows

Qualifications

• College or university degree
• MD, PharmD or degree in life sciences is a plus
• Minimum 7 years of experience in Clinical Research
• Minimum 5 years of industry experience in the capacity of a QA auditor or equivalent
• Must have experience in planning, conducting and reporting all types of quality assurance audits
• Auditing experience in USA
• Excellent knowledge of ICH GCP guidelines, FDA/ EMA regulations, and applicable local regulations
• Team oriented with superior communication and interpersonal skills 
• Strong time management, organizational, planning and presentation skills
• Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
• Intermediate proficiency in MS Office (Word, Excel Power Point, Outlook)
• Must be a reasonably effective public speaker

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Job Description

We are looking for an experienced CRA ready to train and coordinate junior CRAs on site. Here you will have the opportunity to develop yourself as a trainer, mentor and leader. We are committed to develop our employees in their careers by providing tailored courses and mentoring.

Only CVs in English will be considered
Home-based position in Mexico

You will:

• Conduct and report all types of onsite monitoring visits
• Be involved in study startup (if applicable)
• Perform CRF review, source document verification and query resolution
• Be responsible for site communication and management
• Be a point of contact for in-house support services and vendors
• Communicate with internal project teams regarding study progress
• Participate in feasibility research
• Support regulatory team in preparing documents for study submissions

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience
• Independent on-site monitoring experience in Mexico
• Experience in all types of monitoring visits in Phase II and/or III
• Availability to travel
• Experience in Oncology or Infectious Diseases is a plus
• Full working proficiency in English and Spanish
• PC skills to be able to work with MS Word, Excel and PowerPoint
• Ability to plan, deal with different tasks and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills

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Job Description

We are looking for a Quality Assurance Auditor to join us as part of a tight-knit, international team, working across multiple locations and time zones.

You will ensure high quality standards within our clinical trials and internal company processes, and share your expert knowledge with the business. This is an excellent opportunity to work in multiple therapeutic areas and gain exposure to all aspects of the clinical trial process.

This job is home-based in Mexico.

Your responsibilities will include:

• Preparing, conducting, and reporting of QA study audits, internal systems and location audits, vendor qualification audits and maintain relevant communication with the auditee
• Communicating with project teams with regard to QA study audits, including follow-up and resolution
• Assembling QA audits documentation
• Training PSI Operations staff in quality management topics

Please note, this role requires international travel for site audits.

Qualifications

• MD, PharmD or degree in life sciences is a plus
• A minimum of 3 years’ experience in quality management or quality assurance in clinical study environment
• Must have experience in planning, conducting and reporting of QA audits
• Excellent knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws/regulations
• Team oriented with superior communication and interpersonal skills including a proactive attitude to tasks and projects
• Excellent time management skills
• Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
• Full working proficiency in English
• Proficiency in MS Office applications
• Ability to travel

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Job Description

Only CVs in English will be considered

In this position, you will be responsible for coordinating activities of project teams ensuring milestones are met and ensuring consistency of Clinical Operations processes across regions. This function holds project managerial responsibilities under supervision. 

Responsibilities will include: 

• Coordinating project team work, supervising the clinical project team members’ performance, 
• Implementation, and management of projects in compliance with industry regulations, ICH-GCP, essential study documents, and applicable controlled documents,
• Acting as a point of contact for the project team, PSI support services and contractors,
• Collecting and reporting project status updates,
• Developing and updating project planning documents, essential study documents and project manuals/ instructions,
• Conducting and supervising therapeutic area training of the project team and Investigators,
• Supervising preparation, conduct and reporting of site selection, site initiation, routine monitoring and closeout visits and reviewing site visit reports,
• Overseeing investigator and site payments,
• Supervising project team preparation for study audits/inspections and resolution of audit/inspection findings,
• Coordinating preparation of initial and follow-up Regulatory and Ethics Committee submissions and notifications,
• Performing other project management tasks in agreement with the responsible Clinical Operations Manager following adequate and documented training, and formal delegation of tasks.

Qualifications

• College/University degree in Life Sciences or an equivalent combination of education, training & experience,
• Full working proficiency in Spanish and English,
• At least 4 years’ experience in a health care or clinical environment,
• Minimum 4 years’ site monitoring experience and at least 2 years’ experience as Lead Monitor or equivalent,
• Availability to travel,
• Proficiency in MS Office applications
• Ability to plan and work in a dynamic team environment
• Communication, collaboration, and problem-solving skills

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Job Description

We are looking for a Quality Assurance Auditor to join us as part of a tight-knit, international team, working across multiple locations and time zones.

You will ensure high quality standards within our clinical trials and internal company processes, and share your expert knowledge with the business. This is an excellent opportunity to work in multiple therapeutic areas and gain exposure to all aspects of the clinical trial process.

This job is home-based in Mexico.

Your responsibilities will include:

• Preparing, conducting, and reporting of QA study audits, internal systems and location audits, vendor qualification audits and maintain relevant communication with the auditee
• Communicating with project teams with regard to QA study audits, including follow-up and resolution
• Assembling QA audits documentation
• Training PSI Operations staff in quality management topics

Please note, this role requires international travel for site audits.

Qualifications

• MD, PharmD or degree in life sciences is a plus
• A minimum of 3 years’ experience in quality management or quality assurance in clinical study environment
• Must have experience in planning, conducting and reporting of QA audits
• Excellent knowledge of ICH GCP guidelines, EMA and FDA regulations, and applicable local laws/regulations
• Team oriented with superior communication and interpersonal skills including a proactive attitude to tasks and projects
• Excellent time management skills
• Demonstrated ability to meet tight deadlines, multi-task/be flexible and thrive in a fast-paced work environment
• Full working proficiency in English
• Proficiency in MS Office applications
• Ability to travel

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Job Description

As a Site Technology Specialist, you will work with clinical sites and provide technical support and expertise related to technology (Kidney imaging, cell therapy, radiology and renal ultrasounds).

Full-time/Perm

You will:

• Provide clinical sites with technical support and expertise related to technology (Nuclear medicine, kidney imaging, interventional radiology)
• Assist in the design and implementation of study related forms, guidelines and manuals related to technologies
• Coordinate data collection related to technologies, including but not limited to nuclear medicine, radiology, etc.
• Provide technical and initiation support to sites
• Identify, track, and report specific technical timepoints in the study related to study procedures including imaging, scans, and other technologies
• Determine technical resources needed for project implementation, and communicates needs to department managers
• Organize technical training for project teams
• Provide support to the project teams to ensure proper documentation of study-specific assessments related to study technologies
• Support site initiation preparation and performs technical visits to assist the site team with technical aspects of the study
• Assist and advises the site monitor in the area of study technologies
• Provide relevant technology-related information to Business Development for proposals
• Prepare for and attends Bid Defense Meetings
• Attend and presents at Investigator’s Meetings

Qualifications

• BSRT, RN, LPN, and/or equivalent degree 
• Licensed specialist in relevant technology; CNMT required (Certified Nuclear Medicine Technologist).
• Minimum 5 years’ experience in the specified technology: Nuclear Medicine, Molecular imaging, etc. 
• Experience in operation and QC procedures related to overseeing and managing PET imaging agents and therapeutic RLTs
• Proficiency in standard MS Office applications
• Must have the ability to travel (20% of time)
• Must have excellent communication skills and the ability to collaborate while working in a team environment

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