Sr. TMF Specialist

Sr. TMF Specialist

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

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 accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know: 

WORK HERE MATTERS EVERYWHERE

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 our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. 
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong. 

Job Responsibilities

• Process study documentation in accordance with applicable Standard Operating Procedures (SOPs), Work Instructions (WIs), GCP, ICH guidelines and executed study-specific processes/requirements.
• Support the set-up, maintenance, and closure of TMF repositories.
• Support documentation collection activities, including document scanning and indexing for trial using an electronic TMF.
• Ensures the security and compliance of all documents related to active and archived projects.
• Perform Quality Review of documents submitted to the TMF.
• Perform Completeness Review of TMF content against Expected Document Lists to determine missing TMF content.
• Liaise with document owners to resolve any issues identified.
• Escalate issues to the TMF Lead as required and complete administrative tasks (e.g., status reporting)
• Participate in preparation/reconciliation of TMF documentation related to audits, inspections, and shipments.
• Participate in process and study specific trainings as required.
• Maintain compliance with company standard requirements (e.g., time tracking, training), as well as role specific requirements (e.g. Quality, Productivity, utilization)
• Create and cross reference compliance tools/trackers that have been developed to complete compliance check.
• Create expected document list using the TMF reference model with guidance from the TMF / Study team PMs.
• Works in close collaboration with Line Manager to identify TMF best practices, beyond but not limited to quality, productivity, and communication.
• Provide oversight, training, and support to junior members of document management upon management request.
• Assist with the development of work processes and systems to support document management, including contributing to SOPs and internal department guidance.
• Ability to multitask, maintain high level of accuracy and attention to detail.
   

At  Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time.  Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

$47,000.00 - $79,900.00

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate’s qualifications, skills, competencies, and proficiency for the role.