TFS HealthScience - Contract Research Organization

Research Analyst

• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard.
• Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
• Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
• Review CRFs (electronic or paper) and subject source documentation for validity and accuracy.
• Verify proper management and accountability of Investigational Product.
• Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
• Monitoring Close-out visits in Ukraine.

Senior Clinical Research Associate – Freelance

Compliance

• Provide scientific interpretation of preclinical ophthalmology data including in vivo models to assess proof of concept
• Translate nonclinical findings into regulatory and early clinical development recommendations
• Define and guide the overall regulatory and clinical strategy for the program
• Advise on optimal next steps in development including study design and development pathway
• Support planning and execution of interactions with European regulatory authorities including scientific advice
• Recommend appropriate regulatory pathways and authority engagement strategies within Europe

Director, Regulatory Affairs

Manager

• Facilitates the generation and revision of all Quality Management System (QMS) Documents
• Supports the risk assessment, Root Cause Analysis and Corrective Action Preventive Action (CAPA) Plan generation for all Quality Events
• Drives the completion of relevant quality sections of Request for Proposal (RFP)/ Request for Information(RFIs)/quality assessments
• Assists with the Computer System Validation (CSV) of all systems across the company
• Prepare, conduct and follow up internal and vendor audits and the management of the resultant CAPA
• Assists with hosting external audits
• Provides input into the quality section of RFI / RFP and quality assessments
• Maintains a library of questions and robust agreed answers
• Prepares, conducts and follows up on internal GxP audits
• Prepares, conducts and follows up on vendor audits
• Supports and guides operational staff in preparing for customer audits
• Assists with supporting and guiding operational staff in preparing for inspections including analyze risks and develop inspection readiness strategy

Quality Manager

Clinical Research

• Responsible for the planning, performance, report and documentation of statistical tasks during the study process.
• Assist in the development of Study Protocols, CRFs and reports/manuscripts by providing statistical input.
• Write and review the statistical sections in the Study Protocol.
• Ensure CRF design meets specific statistical requirements.
• Perform sample size calculations and define randomisation procedures.
• Write the Statistical Analysis Plan and design the Data Presentation Plan.
• Plan and execute statistical analysis according to protocols.

Biostatistician

Data Scientist

• Act as a Lead Clinical Data Manager
• Coordinate work of other Clinical Data Management staff assigned to the project
• Provide guidance for Data Entry and Data Associates
• Review Study Protocol
• Develop CRF or review sponsor-generated CRFs
• Develop Database
• Prepare, finalize and archive all related DM documentation
• Define and program edit checks
• Develop CRF completion guidelines
• Coordinate validation of database, edit checks and trial and site settings

Clinical Data Manager

QA Engineer

• Act as the QA Responsible Person (RP) for local batch release of medicinal products in the Czech Republic, ensuring compliance with GDP/GMP requirements.
• Perform review and certification of batch documentation for Gilead products, including solid dosage forms (tablets), sterile oncology products, and CAR-T therapies (patient-specific release).
• Ensure compliance with local regulatory requirements and maintain oversight of quality systems and processes.
• Collaborate with global QA, manufacturing sites, and supply chain teams to ensure timely and compliant product release.
• Support and maintain quality management activities, including deviations, CAPAs, change controls, and inspections readiness.

QA Responsible Person, GDP

Director

• Establish and scale TFS's ophthalmology clinical operations presence across LATAM
• Provide end-to-end oversight of Phase I–III clinical trials
• Build regional infrastructure, governance models, KPIs, and performance frameworks
• Act as a hands-on player–coach across multiple areas
• Lead recruitment, onboarding, and mentoring of local clinical operations teams
• Build and strengthen relationships with key stakeholders across LATAM
• Serve as the primary regional escalation point for sponsors and internal leadership
• Partner cross-functionally with global teams

Director – Project Delivery, Ophthalmology

• Independently plan, conduct, and follow up on pre-study, site initiation, routine monitoring, and close-out visits, both on-site and remotely, in line with the applicable monitoring plan
• Oversee study site performance, including recruitment progress, and provide ongoing support to sites on study-related questions and operational issues
• Review eCRF data, timelines, and queries; identify and report protocol deviations; and maintain clear communication with project management and sponsors
• Review and maintain study documentation at site level, including Investigator Site Files (ISF), ensuring inspection readiness and compliance with applicable regulations
• Collaborate cross-functionally with medical, project management, quality management, and data management teams, and support sites during audits and inspections