Trial Data Manager - 7105

CTC Resourcing Solutions; Basel; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

CTC is seeking a Trial Data Manager in the Basel area for an initial 24-month contract. You will lead end-to-end Data Management activities for assigned clinical trials, coordinating eCRF development, data review and queries, and SDTM-related deliverables while partnering with Clinical Development and cross-functional stakeholders.

The role requires at least 3 years in the pharmaceutical/biotech industry, strong data management expertise, and excellent English skills.

Qualifikationen

• Swiss working/residency permit and/or Swiss/EU citizenship required.
• At least 3 years of experience in the pharmaceutical or biotechnology industry within Clinical Research and/or Clinical Data Management.
• Strong expertise in clinical data management, including trial databases, data flow, data review, and eCRF design.
• Experience coordinating or leading Data Managers and other contributors on the same trial.
• Experience managing outsourced Data Management activities or external service partners.

Aufgaben

• Lead Data Management activities for assigned clinical trials and ensure adherence to standards, regulations, and study timelines.
• Provide Data Management input into trial protocols and coordinate eCRF development.
• Author trial-specific Data Management documentation, including external data transfer specifications and data cleaning tools.
• Coordinate and track testing of eCRF screens, data-cleaning tools, and review tools in production.
• Plan, monitor, and drive data cleaning, data review, query management, and database lock with Clinical Development stakeholders.
• Generate trial metrics and status reports, represent Data Management in Clinical Trial Team meetings, and present at investigator and monitor meetings.
• Manage Data Management activities delivered by outsourced or insourced partners and ensure quality and timelines.
• Ensure annotated CRFs are created, validated, and delivered on time; coordinate periodic quality-control checks.
• Forecast trial-team resource requirements and provide training to Data Managers.
• Contribute to Data Management policies, SOPs, and cross-functional improvement initiatives.

Kenntnisse

Data Management

Team Leadership

Project Coordination

Stakeholder management

English

Jobbeschreibung

CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.

Our client is headquartered in Switzerland – a biotech-hub of Europe – is a high-potential biopharmaceutical company, specialized in the discovery, development and commercialization of innovative small molecules, with the aim of transforming the horizon of therapeutic options is looking for a Trial Data Manager for a initial 24 months contract based in Basel area.

The Trial Data Manager leads end-to-end Data Management activities for assigned clinical trials, ensuring high-quality, consistent data delivery in line with internal standards, applicable regulations, and agreed timelines. The role coordinates eCRF development, data review and query management, database lock, and SDTM-related deliverables while partnering closely with Clinical Development and other cross-functional stakeholders.

Main responsibilities:

• Lead Data Management activities for assigned clinical trials and ensure adherence to the company`s standards, applicable regulations, and study timelines.
• Provide Data Management input into clinical trial protocols and coordinate the development of electronic Case Report Forms (eCRFs).
• Author trial-specific Data Management documentation, including specifications for external data transfers, data cleaning, and review tools.
• Coordinate and track testing of eCRF screens, data-cleaning tools, and review tools through implementation in the production environment.
• Plan, monitor, and drive data cleaning, data review, query management, and database lock in collaboration with key Clinical Development stakeholders.
• Generate trial metrics and status reports, represent Data Management in Clinical Trial Team meetings, and present relevant topics at investigator and monitor meetings.
• Manage Data Management activities delivered by outsourced or insourced partners and remain accountable for quality, timelines, and deliverables.
• Ensure annotated CRFs are created, validated, and delivered according to agreed timelines, and coordinate periodic quality-control checks.
• Forecast trial-team resource requirements, ensure assigned Data Managers have the required training, and provide functional direction to colleagues supporting the same trial.
• Contribute to Data Management policies, SOPs, associated documentation, and cross-functional system or process improvement initiatives.
• Act as the Data Manager for studies where no dedicated Data Manager is assigned.

Qualifications and Experience:

• Relevant Swiss working/residency permit and/or Swiss/EU-Citizenship required;
• At least 3 years of experience in the pharmaceutical or biotechnology industry within Clinical Research and/or Clinical Data Management.
• Strong functional expertise in clinical data management, including clinical trial databases and applications, clinical data flow, data review, and eCRF design.
• Experience coordinating or leading Data Managers and other contributors working on the same clinical trial.
• Experience managing outsourced Data Management activities or external service partners is highly relevant.
• Good knowledge of international clinical research regulations and requirements, including ICH Good Clinical Practice (ICH/GCP).
• Ability to organize multiple deliverables, maintain oversight of timelines and quality, and communicate clear priorities.
• Confident collaboration across Clinical Development and other cross-functional stakeholder groups.
• Strong presentation and stakeholder-management skills.
• Advanced written and spoken English.