Head of Compliance Projects

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.

supportive and engaged line management; technical and therapeutic area training; We are committed to building an inclusive culture - where you can authentically be yourself. We are continuously building the company we all want to work for and our customers want to work with. 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.

Project Administration

Creates and maintains the Trial Master File Management (TMF) Plan. Routinely reviews the TMF to ensure quality, completeness and inspection readiness.

Assists with activities associated with interim analyses, database snapshots and locks, final CSR and study closure.

Provides vendor management, inclusive of ensuring key deliverables are met, potential scope creep is identified and change orders are developed, as necessary.

Assists with development and implementation of change orders.

Assists with resource management and team member transition by collaborating with appropriate Resource Managers and ensuring detailed Transition Plans are developed and implemented efficiently.

Develops contingency planning and risk mitigation strategies to ensure meeting or exceeding study milestones.

Creation and maintenance of metric reports, inclusive of data collection from multiple sources, for delivery to client or senior management.

Assists with overall financial performance of the study by interacting with internal functional departments or vendors to obtain required metrics for financial reporting.

Attends financial review meetings to assist with reconciliation and identification of budget overrun.

Reviews and approves invoices from sites or vendors and to the client.

In collaboration with the Project Team, will plan, coordinate and present at internal and external meetings.

Knowledge / Training

Facilitates team training in accordance with protocol and/or project requirements, including therapeutic, protocol specific, and process training.

Bachelor's Degree (or equivalent) level of qualification in Life Sciences, Medicine, Pharmacy, Nursing or related field equivalent preferred.

Prior experience in a contract research organization (CRO), pharmaceutical, or biotechnology company preferred. Strong knowledge of Good Clinical Practice/ICH guidelines and other applicable regulatory requirements.

Strong ability to manage time and work independently.

Flexibility and ability to handle multiple tasks to meet deadlines while delivering high quality work in a dynamic environment.

High level of competency in English language.

Proficiency with MS Office Applications.

Ability to travel as necessary (up to 25%).

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.

Further, nothing contained herein should be construed to create an employment contract. 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.

#J-18808-Ljbffr Syneos Health/ inVentiv Health Commercial LLC