Description

Trial Master File (TMF) Lead II 

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 

This position is a Sponsor-Dedicated/Hybrid TMF Lead II located in Burlington, Ontario, requiring an in-office presence of 10 days per month. The ideal candidate should possess a minimum of 2 years of experience in TMF management, 2 years of experience with Veeva eTMF platform, and at least 3 years of involvement in clinical trials. A four-year college degree is also required for consideration.

 

As a core trial team member, you'll provide operational expertise in implementing TMF strategy across global trials, ensuring inspection-readiness, and maintaining compliance with industry standards. You'll collaborate with trial teams to manage TMF records, oversee outsourced activities, and drive timeliness and quality. Additionally, you'll serve as a subject matter expert, lead Trusted Process meetings, and support eTMF platform engagement. With a focus on risk mitigation and continuous improvement, you'll also prepare for audits and inspections. The role offers professional growth and the flexibility of a hybrid work environment.

What You'll Be Doing:

Core Trial Team Member: Provide operational expertise in overseeing the implementation of the TMF strategy across global trials. Ensure Inspection-Readiness: Maintain TMF activities in compliance with study protocols, regulations, and industry standards (e.g., ICH, GCP, Good Documentation Practices), ensuring your trial is always inspection-ready. Collaboration & Influence: Work closely with trial teams (CT Leader, Site Monitoring Lead, Outsourced Vendors, etc.) to create, implement, and maintain trial-specific TMF records, ensuring accuracy and completeness. Drive Timeliness & Quality: Track and manage TMF trial records in line with internal/external standards, ensuring deadlines are met and quality metrics are maintained. Outsourced Activity Oversight: Oversee outsourced TMF activities, ensuring timely, complete, and high-quality documentation. Subject Matter Expert (SME): Lead Trusted Process meetings (Kick-Offs, Quality Finish Camps), presenting TMF status and collaborating with various teams to drive TMF execution. eTMF Platform Engagement: Provide support for internal and external teams using the eTMF platform, ensuring proper study creation and configuration. Risk Mitigation: Identify TMF risks and develop mitigation strategies to keep your projects on track. Audit/Inspection Preparation: Participate in audits and inspections, ensuring ongoing TMF compliance and maintaining high inspection-readiness. Metrics & Continuous Improvement: Track and report on TMF health, provide actionable feedback, and drive improvements based on TMF trends. Project Ownership: Ensure timely and accurate documentation transfer, Completeness Checks, and submission, all while managing the project’s scope, timeline, and budget.

Qualifications

What we’re looking for

Undergraduate degree Experience in a Contract Research Organization (CRO) or Pharma   , with TMF experience Veeva experience required (familiarity with the Veeva eTMF platform) In-depth knowledge of ICH regulations, Good Clinical Practice (GCP), Good Documentation Practice, and understanding of the legal/regulatory environment concerning sponsor TMF and ISE management Proven experience leading/co-leading global projects from award to close-out Expertise in document management systems (preferably eTMF platforms) 2-5 years of documentation management experience, including knowledge of the clinical trial lifecycle and flow of records Strong proficiency with Microsoft Office Suite (Word, Excel, PowerPoint) Exceptional attention to detail, critical thinking, and organizational skills Ability to manage multiple tasks and deadlines while maintaining quality International/Intercultural/Cross-functional experience is a plus

 

Why This Role?

Global Impact: Contribute to the success of clinical trials on a global scale, ensuring seamless TMF management across diverse teams. Professional Growth: Expand your expertise and grow as a TMF subject matter expert with hands-on experience in audits, inspections, and global project management. Hybrid Flexibility: Enjoy a dynamic client-dedicated hybrid work environment, with 50% of your time in the client’s Burlington office and the other 50% remote, allowing for the best of both worlds—hands-on collaboration and flexible work. Dynamic Environment: Work directly with top-tier clients and contribute to high-stakes, impactful global clinical trials.

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.