Description Trial Master File (TMF) Lead II
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
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.
• 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%). Qualifications 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
.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.