Associate Director, TMF Operations

1001 Syneos Health, LLC; Hyderabad; On-site; INR 3,500,000 - 5,500,000; Full time

Job summary

Syneos Health in Hyderabad, India, seeks an Associate Director of TMF Operations to lead end-to-end TMF lifecycle, ensuring regulatory readiness and optimal document management for global studies. The role demands strategic leadership and deep TMF expertise.

You will oversee large, geographically diverse teams, partner with Clinical Solutions, and drive quality controls and process improvements. Travel up to 50% may be required.

Qualifications

• 10+ years of TMF Operations/Clinical Operations/Clinical Document Management experience.
• Proven leadership including at least 2 years of second-line management experience.
• Strong understanding of eTMF systems, preferably Veeva Vault, and regulatory TMF standards.

Responsibilities

• Oversees salary administration and people-management activities, including development and performance management.
• Facilitates cross-functional processes, resource planning, and communication across departments.
• Plans and negotiates resource allocation with functional leaders to meet business requirements.
• Supports management in training, budget forecasting, and process improvement initiatives.

Skills

TMF Operations

Clinical Operations

Clinical Document Management

Tools

eTMF systems

Veeva Vault

Job description

Associate Director, TMF Operations Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress. Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver – for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.
• We are continuously building the company we all want to work for and our customers want to work with.

Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Oversees salary administration, interviewing and selection, employee development, performance management, job description preparation, employee counseling, and other people-management activities. Provides guidance to staff and managers on administrative policies, operational priorities, technical challenges, and departmental procedures. Facilitates cross-functional processes, resource planning, and communication across departments. Plans and negotiates resource allocation with functional leaders to meet business and project requirements. Serves as a key escalation point for internal and external stakeholders. Supports management in preparing, reviewing, approving, and presenting information during project and departmental review meetings. Develops and implements training programs to enhance team capability and performance. Supports project financial management activities, budgeting, forecasting, and process improvement initiatives. Facilitates project reviews with Clinical Operations teams, focusing on budget, timelines, resource utilization, and risk management. Collects, analyzes, and reports operational metrics to senior leadership. Leads the development, review, and implementation of SOPs and Work Instructions for new and existing processes. Establishes and monitors operational metrics, KPIs, and cycle times to drive performance improvements. Oversees quality control activities and ensures adherence to operational and compliance standards. Sets priorities, manages workload distribution, forecasts demand, and drives workforce and budget planning. Ensures effective delivery of TMF and document management services. Supports business development initiatives and contributes to new business opportunities. Maintains paper and electronic clinical document standards to meet regulatory and organizational requirements. Develops and maintains training materials, process documentation, and best practice guidelines. Represents the organization at professional meetings, client engagements, conferences, and industry seminars. Performs other work‑related duties as assigned. May require moderate travel (up to 50%).

QUALIFICATION

10+ years of experience in TMF Operations, Clinical Operations, or Clinical Document Management. Proven leadership experience, including at least 2 years of second‑line management experience. Experience managing managers and leading large, geographically diverse teams. Strong understanding of eTMF systems, preferably Veeva Vault. Demonstrated expertise in resource planning, capacity management, and operational delivery. Experience within a CRO, pharmaceutical, or biotechnology environment preferred. Strong knowledge of GCP, regulatory requirements, and TMF quality standards. Excellent stakeholder management, communication, and problem‑solving skills.

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever‑changing environment.

Learn more about Syneos Health. http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Discover what our Syneos Health colleagues already know:

work here matters everywhere. Work alongside the brightest minds in the biopharmaceutical industry taking down walls and removing barriers to speed our customers’ delivery of important therapies to patients.

We are strategic thinkers who actively seek different perspectives, whether across offices or across oceans. Because we solve some of the toughest challenges facing the most prestigious healthcare companies today, you’ll gain exposure and be supported with comprehensive resources including emerging technologies, data, science and knowledge sharing.

The diversification and breadth of Syneos Health creates a multitude of career paths and employment opportunities. We’re a growing, global company dedicated to advancing our talent past their initial role.

Discover what our 29,000 employees already know: work here matters everywhere. We work hard, and smart, all in the name of getting much-needed therapies to those who need them most.

A career with Syneos Health means your everyday work improves patients’ lives around the world.

Selecting us as an employer secures a career in which you’re guaranteed to:

• Partner with the most diverse team of experts in the industry.
• From the top down, our people are inspiring.
• Everyone has a voice and is encouraged to use it.
• Work in specialized Syneos Health teams that are therapeutically or functionally aligned for expert collaboration.
• We assemble clinical teams where everyone, from CRAs to senior management, is skilled in the same therapeutic area or customer teams. With this structure, everyone on your team speaks the same language and can deliver unique insights into the therapeutic environment and patient population.
• We are partners with purpose. We integrate seamlessly with our customers and do what’s best for their success. Our people provide the brilliant ideas, valuable insights and endless energy that accelerates the impact of life changing therapies worldwide.