Senior Clinical Trial Data Management & Archiving Expert (m/w/d)

Project overview

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

Requirements

• 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

ASAP, ideally within the next 2 weeks

Approx. 6 weeks, until before Christmas; possible extension in the new year

Capacity: min. 50% FTE or more

• Start: ASAP
• Duration: 1 month
• Remote: remote
• Location: Switzerland, CH
• Languages: English