Clinical Operations Document Manager (Pharmaceutical, Copenhagen)

Job summary

The Clinical Operations Document Manager plays a crucial role in ensuring the completeness, compliance, and inspection readiness of clinical trial documentation within the Global Clinical Operations organization. This position involves overseeing the electronic Trial Master File (eTMF) and collaborating with various stakeholders to maintain high-quality standards throughout the trial lifecycle.

Qualifications

• Solid experience in clinical trial documentation and eTMF management within the pharmaceutical sector.
• Proficiency in governing eTMF systems, including Expected Document Lists and quality oversight.
• Knowledge of ICH-GCP and regulatory requirements for inspection-ready documentation.
• Ability to educate others on TMF requirements and processes.
• Strong independent working skills with a structured and proactive approach.
• Excellent collaboration skills with global stakeholders and external partners.
• Fluent communication skills in English, both written and verbal.

Responsibilities

• Act as the TMF manager, ensuring proper setup, maintenance, and quality oversight of the eTMF across clinical trials.
• Perform ongoing quality checks and support inspection and audit activities.
• Provide guidance on documentation expectations and eTMF best practices throughout the trial lifecycle.
• Collaborate with cross-functional teams to enhance trial execution quality.

Skills

• Strong attention to detail and a focus on quality.
• Effective problem-solving and collaboration abilities.
• Proficient in using VEEVA eTMF and other relevant tools.

Education

• Relevant degree or equivalent experience in a related field.

Tools

• eTMF systems, VEEVA eTMF.