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:
 
Why Syneos Health
• 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.