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Fully Remote
4 weeks ago
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.
supportive and engaged line management; technical and therapeutic area training; We are continuously building the company we all want to work for and our customers want to work with. 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.
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 . You'll collaborate with trial teams to manage TMF records, oversee outsourced activities, and drive timeliness and quality. With a focus on risk mitigation and continuous improvement, you'll also prepare for audits and inspections. Core Trial Team Member : Provide operational expertise in overseeing the implementation of the TMF strategy across global trials.
Collaboration & Influence : Work closely with trial teams (CT Leader, Site Monitoring Lead, Outsourced Vendors, etc.) 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.
Risk Mitigation : Identify TMF risks and develop mitigation strategies to keep your projects on track.
Project Ownership : Ensure timely and accurate documentation transfer, Completeness Checks, and submission, all while managing the project’s scope, timeline, and budget.
Undergraduate degree
Experience in a Contract Research Organization (CRO) or Pharma , with TMF experience
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)
Ability to manage multiple tasks and deadlines while maintaining quality
International/Intercultural/Cross-functional experience is a plus
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.
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.
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.
Further, nothing contained herein should be construed to create an employment contract. 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.
