Sr TMF Lead at Syneos Health in

Description

Senior Trial Master File (TMF) Lead

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

Attends Trusted Process meetings such as Kick-Off Meetings, QuickStart Camps, Quality Finish Camps, etc. as TMF Subject Matter Expert (SME) and successfully communicates and presents TMF status updates and seeks relevant information to drive the execution/delivery of the TMF.
Collaborates with the Project Lead (PL) and Functional Leads (FL) to ensure TMF documentation is submitted in a timely manner. Actively involved in risk management/mitigation to ensure a high quality audit-ready TMF. Develops plans to increase compliance and follows up on non-compliance, if applicable.
Attends internal project team and sponsor teleconferences and face-to-face meetings as TMF SME, as applicable, to the project/program.
May provide input to Functional Service Provider (FSP) TMF proposals and participate in new business opportunities. Supports TMF Management by contributing to customer solutions/proposals and any associated costing.
Designs and/or delivers applicable project-specific TMF training in various formats via teleconference, video conference, and/or in person.
Monitors and reports on TMF Health, including identifying risks, issues and mitigation plans for the project.
Prepares and participates in audits/inspections to ensure ongoing inspection-readiness of the TMF.
Provides regular feedback to the Project Team on TMF Health/status including actionable metrics for projects/programs. Provides re-training to the Project Team, as necessary, based on TMF trends.
Identifies TMF best practices and leads/participates in TMF process improvement initiatives and the maintenance of the TMF best practices information and any other relevant documentation.
Presents monthly TMF status, risks, issues and associated actions for assigned projects during project meetings.
Provides timelines to the Project Team and TMF Operations Team for the TMF transfer, including timelines for final Completeness Checks, document submissions, TMF Export and QC and transfer to the client.
Ensures a thorough understanding of contracted scope, timeline, and budget for the TMF. Works with department management to monitor TMF team performance to the budget and communicates any out-of-scope work to the Project Lead to add to a Change Notification Form/Change Order, as required.
Mentors and provides training to TMF Leads on all TMF Lead responsibilities.
Develops and enhances training material applicable to TMF Lead responsibilities for the department.
May participate in department and business unit improvement initiatives.
May be involved in the interview and candidate selection process.
May act as a team lead providing support, guidance and recommendations to a team of TMF Leads.
May manage employees per customer account requirements.
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

Qualifications

What we're looking for

Undergraduate degree in the life sciences, business administration, or related discipline.
Experience in a Contract Research Organization or related field.
Trial Master File experience preferred.
Experience with leading/co-leading studies from award into maintenance through close-out on a global scale.
Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
Skill should include above average attention to detail, critical thinking, organizational, interpersonal, and collaboration.
Ability to perform several tasks simultaneously to meet deadlines.

Syneos Health has a voluntary COVID-19 vaccination policy. We strongly encourage all employees to be fully vaccinated. Additionally, certain local governments or Syneos Health customers may have vaccine requirements that apply to some of our employees. These employees are required to submit proof of vaccination to Syneos Health and maintain compliance with these requirements.

AtSyneos 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.

The annual base salary for this position ranges from USD $75,150- $99,300. 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.

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.

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.