Apply for Parexel Hiring for Clinical Operations Manager TMF in Bengaluru. Lead TMF quality, compliance, process improvements, and clinical support.
Parexel, one of the world’s leading Clinical Research Organizations (CROs), is inviting applications for the position of Clinical Operations Manager – TMF (Trial Master File) at its Bengaluru location. Parexel is known globally for its strong commitment to improving human health, supporting clinical trials, regulatory operations, consulting, and all aspects of clinical development. Every individual working at Parexel contributes to advancing medical science, ensuring patient safety, and accelerating therapies that can transform lives. Parexel Hiring for Clinical Operations Manager TMF
This role is ideal for experienced clinical operations professionals who possess substantial TMF management experience, a deep understanding of GCP guidelines, and the ability to support large-scale clinical projects. As a Clinical Operations Manager, you will be responsible for ensuring quality, compliance, documentation accuracy, and operational excellence across TMF processes. Parexel Hiring for Clinical Operations Manager TMF
The following long-format post provides comprehensive details about responsibilities, skills, work expectations, educational qualifications, and the application process. Parexel Hiring for Clinical Operations Manager TMF
About Parexel
Parexel partners with top pharmaceutical companies, biotechnology firms, and medical device organizations across the world. Its mission is rooted in contributing to global health by delivering high-quality clinical development solutions. With operations spread across multiple continents, Parexel is driven by integrity, innovation, quality, and patient-centric values. Parexel Hiring for Clinical Operations Manager TMF
The company places emphasis on strong ethical practices and teamwork. Every role within the organization is linked to a larger purpose: creating therapies that benefit patients. This shared mission brings alignment, passion, and a sense of responsibility across every department. Parexel Hiring for Clinical Operations Manager TMF
Role Overview: Clinical Operations Manager – TMF
Job Title: Clinical Operations Manager
Department: TMF (Trial Master File)
Location: Bengaluru, India
Job Type: Full-Time
Requisition ID: R0000036741
Posted: Today
The Clinical Operations Manager for TMF is responsible for oversight, quality review, process improvements, and compliance-based TMF documentation activities. TMF is a critical component of clinical operations, as it contains essential documents that demonstrate adherence to standards, sponsor requirements, and regulatory expectations. This role requires strong leadership abilities, analytical thinking, and deep knowledge of clinical research guidelines. Parexel Hiring for Clinical Operations Manager TMF
Key Responsibilities
The position involves strategic, operational, and quality-focused responsibilities. These include: Parexel Hiring for Clinical Operations Manager TMF
1. Operational Excellence
Operational quality is a key expectation from TMF managers. You will be responsible for:
Evaluating TMF Deliverables
- Reviewing the quality of TMF team outputs such as TMF overviews, documentation compliance, indexing accuracy, filing timelines, and query quality.
- Identifying gaps or discrepancies in documentation and proposing corrective or preventive measures.
- Ensuring that the TMF is always inspection-ready and aligned with sponsor expectations.
Ensuring Regulatory Compliance
- Maintaining a strong understanding of ICH Guidelines, Good Clinical Practices (GCP), and applicable regulatory agency requirements.
- Implementing changes or updates in Parexel Standard Operating Procedures (SOPs) within TMF operations.
- Ensuring strict adherence to global and local guidelines to support inspections without deviations.
Participating in System Improvements
- Supporting development, enhancement, and implementation of TMF-related standards and systems.
- Identifying inefficiencies in workflows and recommending improvements.
- Working closely with process owners to refine TMF tools, templates, and operational aids.
Cross-Department Interaction
- Liaising with senior functional management to provide feedback on TMF processes.
- Offering support to project teams when required for smooth TMF implementation.
- Sharing expertise during audits, kick-off meetings, and clinical project discussions.
2. Business and Financial Management
A Clinical Operations Manager also contributes to project-level business activities such as:
- Facilitating the collection of TMF-related metrics.
- Providing consultations to project leaders and management teams to ensure timelines and budgets are met.
- Supporting the preparation of TMF business proposals and maintaining documentation libraries.
- Developing action plans to improve TMF quality or timelines based on client expectations.
3. Personal Ownership
This role requires strong ownership and accountability. Responsibilities include:
- Managing individual assignments as a Subject Matter Expert (SME) and ensuring on-time completion.
- Acting as a senior representative in project teams and supporting TMF operations with advanced knowledge.
- Ensuring administrative responsibilities are completed promptly, such as:
- Timesheets
- Travel expenses
- Metric submissions
- Internal reporting
You may also supervise or guide junior TMF associates and support their professional development. Parexel Hiring for Clinical Operations Manager TMF
Required Skills and Competencies
Parexel expects candidates to demonstrate the following skills: Parexel Hiring for Clinical Operations Manager TMF
Technical Skills
- Strong understanding of Trial Master File structures and clinical documentation.
- Familiarity with TMF systems, indexing, filing, quality assessment, and audit readiness.
- Ability to interpret regulatory guidelines and apply them in real-world scenarios.
Communication Skills
- Excellent verbal and written communication abilities.
- Experience in creating presentations for internal teams or external clients.
- Confidence in presenting at meetings, training sessions, or conferences.
Interpersonal and Analytical Abilities
- Client-focused approach and capability to handle multiple stakeholders.
- Strong analytical abilities and problem-solving skills.
- Negotiation skills and experience in handling project complexities.
- Ability to work effectively in a matrix environment.
Soft Skills
- Flexibility to adapt to changing assignments.
- Ability to manage multiple tasks with attention to detail.
- Strong networking capability and teamwork orientation.
Knowledge and Experience Requirements
Candidates should possess:
- Substantial experience in Trial Master File coordination or strong experience in clinical operations with TMF exposure.
- Ability to review TMF documentation, conduct quality checks, and ensure audit readiness.
- Knowledge of regulatory requirements, sponsor expectations, and documentation standards.
Educational Requirements
- Degree in Biological Sciences, Pharmacy, Life Sciences, or a related health discipline is preferred.
- Candidates with relevant clinical operations or documentation management experience may also be considered.
- Parexel Hiring for Clinical Operations Manager TMF
Why Work at Parexel?
Parexel offers:
- A purpose-driven work culture.
- Opportunities for global exposure and career advancement.
- Training and professional development support.
- A collaborative work environment with access to global experts.
- Diverse projects in clinical operations, regulatory affairs, and TMF management.
- Ethical, structured, and patient-centric organizational values.
Work Environment
This is a full-time position based in Bengaluru. The environment includes:
- Monday to Friday work schedule.
- Collaborative cross-functional teamwork.
- Exposure to global projects and clients.
- Opportunities for remote collaboration depending on project needs.
How to Apply
To apply for the Clinical Operations Manager – TMF position at Parexel:
- Visit the official Parexel Careers website.
- Search using the Job Requisition ID: R0000036741.
- Fill in your personal details and upload your updated resume.
- Ensure you provide accurate information regarding your work experience and TMF expertise.
- Submit the application and monitor your email for updates from the recruitment team.
Candidates are advised to apply early, as this position may close once sufficient applications are received. Parexel Hiring for Clinical Operations Manager TMF
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