Novotech is a full-service global Contract Research Organization (CRO) specializing in clinical trials across all phases. Headquartered in Sydney, Australia, Novotech has 34 offices worldwide, with over 3,000 employees and 5,000+ site partnerships. The company is ISO 27001 and ISO 9001 certified, ensuring high IT security and quality standards for clinical research.
Why Join Novotech?
✅ Global CRO with career growth opportunities
✅ Inclusive workplace (LGBTIQ+, disability-friendly, equal opportunity employer)
✅ Flexible work options, paid parental leave, wellness programs
✅ Supportive culture fostering collaboration & innovation
Job Description: Document Management Associate (DMA)
Key Responsibilities:
✔ Manage Trial Master Files (TMF) – Maintain electronic & paper TMFs per ICH-GCP, regulatory requirements, and Novotech/client SOPs.
✔ Document Quality Control – Review, scan, upload, and track study documents in SharePoint, eTMF, and paper files.
✔ Ensure TMF is “Inspection-Ready” – File documents contemporaneously for audits/regulatory reviews.
✔ Generate Reports – Track document quality, collection timelines, and compliance.
✔ Support Audits & Closeouts – Prepare TMF for regulatory inspections, audits, and study closeout.
✔ Cross-functional Collaboration – Work with clinical teams, sponsors, and third-party vendors.
Skills & Experience Required:
- 12+ months in a CRO/pharma/healthcare setting (TMF experience preferred).
- Knowledge of ICH-GCP, eTMF systems, and regulatory requirements.
- Proficiency in SharePoint, document tracking, and quality checks.
- Detail-oriented with strong organizational skills.
Eligibility & Benefits
Minimum Qualifications:
- Bachelor’s degree in Life Sciences, Pharmacy, or related field.
- Prior TMF (paper/eTMF) handling experience.
- Strong communication & teamwork skills.
Employee Benefits at Novotech:
🌍 Flexible work arrangements
👶 Paid parental leave (for both parents)
🏥 Wellness & development programs
💼 Inclusive & diverse workplace
📈 Career growth in a global CRO
How to Apply
📅 Last Date: August 30, 2025
