Trial Data Manager (7105)

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

Zusammenfassung

CTC Resourcing Solutions AG, on behalf of The Life Science Career Network, is seeking a Trial Data Manager for an initial 24-month contract based in the Basel area. You will lead end-to-end Data Management activities for assigned clinical trials, ensuring quality data delivery and compliance with ICH-GCP.

Responsibilities include eCRF development, data cleaning and query management, database lock, SDTM deliverables, and collaboration with Clinical Development teams.

Qualifikationen

• 3+ years of experience in pharmaceutical/biotech clinical data management.
• Experience with eCRF design and data handling.
• Strong knowledge of ICH-GCP and data standards.

Aufgaben

• Lead data management activities for assigned trials, ensuring quality and timelines.
• Coordinate development of eCRFs and data review processes.
• Create trial-specific DM documentation and external data transfer specs.
• Test eCRF screens, data-cleaning tools, and review tools in production.
• Monitor data cleaning, review, queries, and database lock with stakeholders.
• Generate trial metrics and present in investigator/monitor meetings.
• Oversee DM work by partners and ensure timelines and deliverables.
• Ensure annotated CRFs are created, validated, and delivered on time.
• Plan resource needs and provide training to DM staff.
• Contribute to DM policies and cross-functional improvements.
• Act as DM for studies without a dedicated DM.

Kenntnisse

Clinical data management

eCRF design

Data cleaning

Query management

Stakeholder management

English proficiency

Tools

eCRF systems

Clinical trial databases

Jobbeschreibung

The Life Science Career Network

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.