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Senior Clinical Trial Data Management & Archiving Expert
Responsibilities:
Develop and/or refine a Clinical Trial Data Archiving & Management Strategy
Define a structured approach for what clinical trial data and documentation should be archived, how, and when
Support the development of a tiering/classification model for clinical trial data and records
Assess existing clinical trial data, processes and archiving requirements
Provide expertise in TMF/eTMF, Clinical Data Management and Records Management
Ensure alignment with relevant EMA, FDA and ICH-GCP requirements
Collaborate with Clinical, Data Management and other relevant stakeholders
Translate findings into practical recommendations and, where required, an implementation roadmap
Work within the existing clinical trial environment, including Medidata
Qualifications:
Minimum 6–7 years of relevant experience within clinical trials
Strong background in Clinical Trial Archiving, Clinical Data Management, TMF/eTMF and/or Records Management
Good understanding of EMA/FDA regulations and ICH-GCP
Experience with clinical trial systems; Medidata experience is an advantage
Experience with data lifecycle, retention, archiving or data governance concepts is beneficial
Ability to combine strategic/conceptual work with hands-on expertise
Senior stakeholder management and consulting skills
Project Details:
Start: ASAP, ideally within the next 2 weeks
Duration: Approx. 6 weeks, until before Christmas; possible extension in the new year
Capacity: min. 50% FTE or more
Location: Remote
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