# Manager, TMF Operations

**Company**: ICON
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://icon.wd3.myworkdayjobs.com/en-US/broadbean_external/job/India-Chennai/Manager---TMF-Operations_JR156761?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_3f3527ae-d88

## Description

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a Manager, Trial Master File (TMF) Operations at ICON, you will oversee the management, maintenance, and compliance of the Trial Master File (TMF) for clinical research studies.

**Responsibilities:**

- Managing the TMF Operations team responsible for maintaining the Trial Master File (TMF) across multiple clinical studies, ensuring compliance with GCP and regulatory requirements.

- Overseeing the collection, review, and filing of essential documents, ensuring timely and accurate updates to the TMF throughout the clinical trial lifecycle.

- Collaborating with cross-functional teams, including clinical operations, regulatory affairs, and quality assurance, to ensure TMF completeness and readiness for audits and inspections.

- Developing and implementing TMF management strategies, policies, and procedures to improve efficiency and ensure adherence to industry standards.

- Monitoring TMF quality metrics, identifying areas for improvement, and driving continuous process enhancements.

- Providing leadership and training to TMF staff, fostering a culture of quality and compliance within the team.

- Ensuring readiness of TMF for regulatory audits and client inspections, addressing any findings or gaps in documentation as needed.

**Your Profile:**

- Bachelor's degree in life sciences, documentation management, or a related discipline

- Extensive experience in TMF management or clinical operations within the pharmaceutical or clinical research industry.

- Strong understanding of GCP, ICH guidelines, and global regulatory requirements related to TMF management and clinical trial documentation.

- Proven leadership skills, with experience managing and developing teams in a fast-paced, regulated environment.

- Excellent organisational and project management skills, with the ability to oversee multiple clinical studies and maintain high standards of documentation.

- Strong communication and interpersonal skills, with experience collaborating with cross-functional teams and external stakeholders.

- Proficiency in electronic TMF systems and document management tools, with a focus on maintaining regulatory compliance and audit readiness.

- Willingness to travel as required (approximately 25%)

**Rewards & Benefits**

- Competitive base salary and performance-related incentives

- Health and wellbeing programmes including medical, dental, and vision coverage where applicable

- Retirement and pension plans

- Life assurance and disability coverage

- Employee assistance programmes and wellbeing resources

- Learning and development opportunities through structured training and career pathways

## Skills

### Required
- GCP
- ICH guidelines
- TMF management
- clinical operations
- leadership
- project management
- document management
- regulatory compliance

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