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Parexel, a global leader in clinical research, is hiring a Clinical Operations Manager – Trial Master File (TMF) in Bengaluru. This is an excellent opportunity for experienced TMF professionals looking to grow into a senior strategic operations role. If you want to work on large-scale global clinical studies and play a crucial role in operational excellence, compliance, and process innovation—this opening at Parexel is tailored for you.
🔹 Job Responsibilities
Operational Excellence
- Ensure the quality and compliance of TMF deliverables.
- Review TMF overviews, process steps, document quality, and queries.
- Maintain strong knowledge of ICH GCP, regulatory guidelines, and Parexel SOPs.
- Participate in system and standards improvement initiatives.
- Liaise with senior functional leaders for process alignment & feedback.
- Support SOP, tools, and job aid development with Process Owners.
- Provide internal SME support to project teams during TMF implementation.
- Complete administrative tasks (timesheets, metrics, expenses) on time.
Business & Financial Management
- Assist with TMF metrics, performance tracking, and action plans.
- Support budgets, timelines, and operational improvements.
- Contribute to TMF business opportunity materials and library management.
Personal Ownership
- Act as SME for assigned projects; ensure timely, high-quality deliverables.
- Mentor or guide cross-functional teams when required.
🔹 Skills & Competencies
- Strong experience in TMF coordination or similar clinical operations functions.
- Excellent verbal, written, and presentation skills.
- Strong analytical, negotiation, and stakeholder management abilities.
- Ability to multitask in a matrix environment with attention to detail.
- Client-focused, adaptable, and proactive problem solver.
- Advanced networking skills and ability to guide internal teams.
🔹 Education & Experience
- Bachelor’s degree in Life Sciences, Pharmacy, Biological Sciences, or equivalent.
- Substantial hands-on experience in TMF operations, clinical documentation, or clinical operations management.
🔹 Benefits of Working at Parexel
- Opportunity to contribute to global health advancements.
- Work with world-class clinical research experts.
- Growth pathways in clinical operations & TMF leadership.
- Supportive, collaborative, and people-first workplace culture.
- Exposure to global clients and complex clinical programs.
🔹 How to Apply
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