Novotech, a leading clinical research organisation, is seeking a skilled Document Management Associate (DMA) to join its team. This role involves managing Trial Master Files (TMF) for clinical trials, ensuring compliance with regulatory requirements and company SOPs.
🧾About the Role
As a Document Management Associate, you will play a critical role in supporting clinical teams by managing TMFs, both electronic and paper-based. Your primary responsibilities will include:
TMF Management: Setting up, receiving, tracking, and maintaining electronic or paper TMFs according to project requirements and regulatory guidelines.
Document Quality: Reviewing documents for quality and ensuring they meet Novotech’s essential document requirements.
Reporting: Providing reports on study document quality and collection practices, and ensuring the TMF is ‘inspection ready’ at all times.
Collaboration: Working with project teams to ensure study documents are of high quality and filed contemporaneously.
🎓Requirements
Experience: At least 12 months of experience in a clinical research organisation or equivalent.
TMF Experience: Practical experience in handling Trial Master File activities, including paper or electronic-TMF (eTMF).
Skills:
Strong understanding of ICH GCP guidelines and regulatory requirements.
Excellent organisational and analytical skills.
Ability to work independently and prioritise tasks effectively.
💼What We Offer
Career Growth: Opportunities for professional development and growth in a leading clinical research organisation.
Collaborative Environment: A dynamic and supportive team environment.
Competitive Benefits: Competitive salary and benefits package, including flexible working options and wellness programs.
🌍Why Choose Novotech?
Industry Leader: Opportunity to work with a leading clinical research organisation.
Innovative Culture: A company that values innovation, quality, and people.
Diversity and Inclusion: A commitment to diversity and inclusion, with a focus on creating a workplace where everyone can thrive.
📩 How to Apply
If you’re ready to advance your career in clinical research, apply now!
👉 Apply Here