TMF Lead II
Home-Based, United States
Posted on: June 22, 2022
Closing: July 22, 2022
Trial Master File (TMF) Lead II
Come discover what our 25,000+ employees already know: work here matters everywhere. We're a growing and evolving biopharmaceutical industry leader, which means you'll have endless opportunities to work with experts around the world and build the career you've dreamed of.
As a part of the Syneos Health team, you'll help us deliver results for a rewarding reason - we improve patients' lives around the world. Because to us, a patient isn't just a number, they're our family, friends, and neighbors.
Why Syneos Health
• #SyneosHealthLife means we're committed to our Total Self culture - where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person's unique contributions make a difference.
• We believe our success is a direct result of the people who are driving it - you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That's why we offer a comprehensive benefits program encompassing your total health - physical, mental and financial.
• 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.
• Attends Trusted Process meetings such as Kick-Off Meetings, QuickStart Camps, Jump Start 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.
• May provide support to Senior TMF Leads with various study specific tasks.
• Evaluates and provides recommendations on optimal TMF oversight and verifies studies have been properly created and configured within the eTMF platform.
• Monitor TMF completeness by initiating Completeness Checks and generating TMF completeness reports.
• Actively involved in the eTMF platform including training for the internal or external team members, as applicable.
• Collaborates with the Project Lead (PL) and Functional Leads (FL) to ensure TMF documentation is submitted/published in a timely manner and with high quality in order to maintain the TMF in an inspection-ready state. 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.
• Delivers project-specific TMF training in various formats via teleconference, video conference, and/or in person.
• Prepares and participates in project-specific audits/inspections to ensure ongoing readiness of the TMF. May participate in qualification audits as an area of growth and development.
• Provides regular feedback to the Project Team on TMF health/status, including actionable metrics. Provides re-training to the Project Team, as necessary.
• Provides timelines to the Project Team and TMF Operations Team for the TMF Shipment, including timelines for final Completeness Checks, document submissions/publishing, TMF Export and QC and shipment to the client.
• Ensures thorough understanding of contracted scope, timeline, and budget for the TMF. Documents any out-of-scope work and communicates this to the Project Lead to add to a Change Notification Form/Change Order, as required.
• Presents monthly TMF status, risks, issues and associated actions for assigned projects during the TMF Operations Project Review Meeting (PRM).
• Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).
What we're looking for
• Undergraduate Degree preferred.
• Experience in a Contract Research Organization or related field.
• Experience with leading/co-leading projects from award into maintenance through close-out on a global scale.
• Proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint), email, and voicemail.
• Above average attention to detail, accuracy, and organizational, interpersonal, and team-oriented skills.
• Ability to perform several tasks simultaneously to meet deadlines.
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
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.
Posted on: June 22, 2022
Closing: July 22, 2022