Manager - TMF Operations

ICON; Chennai; Presencial; INR 1.500.000 - 2.300.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Annual leave

Health insurance

Retirement planning

Employee assistance program

Life insurance

Descripción de la vacante

ICON is a global healthcare intelligence and clinical research organization delivering trials with integrity, collaboration, and inclusion at its core. The Manager, TMF Operations will lead TMF management across studies, ensuring GCP and regulatory compliance and timely document updates throughout the trial lifecycle.

You will oversee a TMF team, drive continuous process improvements, and coordinate with clinical operations, regulatory affairs, and QA to maintain audit readiness and high-quality

Formación

• Bachelor's degree in life sciences, documentation management, or a related discipline.
• Extensive TMF management or clinical operations experience in pharma/clinical research.
• Strong understanding of GCP, ICH guidelines, and global regulatory TMF requirements.
• Proven leadership skills in fast-paced regulated environments.
• Excellent organizational and project management skills for multiple studies.
• Strong communication and stakeholder management skills.
• Proficiency with electronic TMF systems and documentation tools.

Responsabilidades

• Oversee TMF operations workstreams, ensuring quality and timelines.
• Manage TMF across multiple studies with regulatory compliance.
• Collaborate with clinical operations, regulatory affairs, and QA to ensure TMF completeness for audits.
• Develop and implement TMF policies to improve efficiency and compliance.
• Monitor TMF quality metrics and drive continuous improvements.
• Provide leadership and training to TMF staff.
• Ensure TMF readiness for regulatory audits and client inspections.

Conocimientos

Trial master file management

Leadership

Regulatory knowledge

GCP/ICH knowledge

Project management

Cross-functional collaboration

Educación

Bachelor's degree in life sciences

Herramientas

Electronic TMF systems

Document management tools

Descripción del empleo

Manager, TMF Operations

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 values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

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.

What You Will Do:

You will oversee trial master file management workstreams, ensuring deliverables meet quality and timeline expectations.

Key responsibilities include:

• 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:

You will have solid trial master file management experience, with the ability to manage competing priorities and develop your team.

Required qualifications and experience:

• 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 organizational 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%)

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• Various annual leave entitlements


• A range of health insurance offerings to suit you and your family’s needs.


• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.


• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.


• Life assurance


• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know or submit a request here

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply