TMF and Clinical Documentation Head

Discera Search; Köln; Remote; EUR 60.000 - 95.000; Vollzeit

Zusammenfassung

An established industry player in pharmaceuticals is seeking a TMF and Clinical Documentation Associate Director. This remote role offers a unique opportunity to lead the documentation strategy across global studies, ensuring compliance and quality standards are met. You will manage a dedicated team and collaborate with internal and external partners to enhance documentation processes. With a flexible work model and a focus on high-impact functions, this position is ideal for professionals eager to shape best practices in clinical trials. Join a company with an active development pipeline and make a significant impact in the field.

Leistungen

Flexible Work Model

Relocation Support

Qualifikationen

• Experience in clinical research or document management in pharma or biotech.
• Strong knowledge of clinical trial documentation and GCP systems.

Aufgaben

• Manage a team maintaining the Trial Master File and study documentation.
• Oversee documentation strategy and ensure compliance with regulations.

Kenntnisse

Clinical Research

Document Management

GCP-aligned Systems

eTMF Tools

Leadership

Project Coordination

Tools

eTMF

Jobbeschreibung

TMF and Clinical Documentation Associate Director. Remote position with the HQ in Berlin.

A global pharmaceutical company with a growing clinical pipeline is hiring a senior professional to take leadership over its documentation and TMF strategy across multiple global studies .

This person will be responsible for overseeing the full document management lifecycle of clinical trial documentation — from the implementation of standards and systems to oversight of inspection-readiness activities. You’ll work closely with internal teams and external vendors to ensure that all clinical records are maintained to the highest compliance and quality standards.

Core Responsibilities

• Manage and guide a team responsible for maintaining the Trial Master File and other regulated study documentation
• Oversee documentation strategy across studies run internally or with CRO partners
• Ensure alignment with global regulations (ICH-GCP) and internal quality systems
• Maintain control of digital documentation tools (e.g., eTMF) and help drive implementation or upgrades
• Lead documentation planning for audits, inspections, and long-term archiving
• Identify process gaps and propose scalable, compliant improvements
• Support cross-functional collaboration with Clinical Operations, QA, and Regulatory Affairs

Candidate Requirements

• Background in clinical research or document management within the pharmaceutical, biotech, CRO or other life science field.
• Strong experience working with clinical trial documentation and GCP-aligned systems
• Hands-on knowledge of electronic Trial Master Forms (eTMF) tools and document lifecycle management
• Leadership - ideally you have previous line management experience but open to those who have only mentored / relevant coaching etc experience.
• Experience managing documentation processes across international studies which can cover any area (Regulatory, Audit, Clinical Trial Documentation, Trial Readiness).
• Strong communication and project coordination skills
• Based in the EU (Germany preferred); relocation support available for the right candidate - visa support not provided at this time.

What’s Offered

• Opportunity to take ownership of a high-impact function in a company with an active development pipeline
• Flexible work model and opportunity to shape internal documentation frameworks

If you’ve built or improved TMF and document control systems and want to take the lead in shaping best practices across trials, we want to like to hear from you.