Clinical Operations Manager – TMF
Location: Bengaluru, India
Job Type: Full-Time, Regular
Experience Required: Fresher – 3+ years
About Parexel
Parexel is a global leader in clinical research services, dedicated to accelerating the development of innovative therapies while ensuring patient safety and regulatory compliance. The organization offers end-to-end clinical operations support across therapeutic areas, providing opportunities for career growth and professional development in a dynamic, collaborative environment.
Role Overview
The Clinical Operations Manager – Trial Master File (TMF) oversees the quality, compliance, and operational efficiency of TMF activities. This role contributes to system and process improvement initiatives while supporting project teams and clients in implementing robust clinical trial documentation practices. This position is ideal for freshers with a relevant degree seeking to build expertise in clinical operations and TMF management.
Key Responsibilities
Operational Excellence
Ensure high-quality TMF deliverables by reviewing completeness, compliance with SOPs, and resolution of queries; recommend corrective actions when needed.
Maintain working knowledge of ICH Guidelines, Good Clinical Practice (GCP), regulatory requirements, and Parexel SOPs.
Participate in system and process improvement initiatives within Parexel and the TMF department.
Serve as an internal Subject Matter Expert (SME) for project teams, providing guidance on TMF operations.
Support development and updates of SOPs, job aids, and training materials for TMF operations.
Complete routine administrative tasks including timesheets, metrics reporting, and travel documentation.
Business & Financial Management
Collaborate with management, project leadership, and team leads to track project progress, manage timelines, and maintain budget compliance.
Support development of business materials and TMF-related proposals, ensuring operational readiness.
Personal Ownership
Act as a senior-level contributor or SME on assigned projects, ensuring timely and high-quality delivery of all responsibilities.
Provide guidance and mentorship to junior staff or cross-functional stakeholders as needed.
Required Skills & Competencies
Strong interpersonal, verbal, and written communication skills, including experience presenting at meetings or training sessions.
Client-focused, professional approach with the ability to adapt to new assignments and learning opportunities.
Ability to manage multiple tasks simultaneously, prioritize workload, and maintain attention to detail.
Analytical and problem-solving skills with a proactive approach to resolving operational issues.
Ability to work effectively in a matrix team environment and build collaborative relationships.
Negotiation, networking, and stakeholder management skills.
Educational Requirements
Bachelor’s degree in Biological Sciences, Pharmacy, or other health-related disciplines.
Relevant clinical or business equivalent experience will be considered.
Experience
Fresher-friendly: Open to candidates with minimal or no prior clinical operations experience.
Internship or academic exposure in clinical research, TMF, or clinical documentation is advantageous.
Why Join Parexel
Gain exposure to global clinical trials and TMF operations.
Develop professional expertise in clinical documentation, regulatory compliance, and trial management.
Work in a dynamic, collaborative environment with opportunities for career progression.
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