Join Syneos Health as a TMF Lead I and Drive Clinical Trial Success!
Summary: Are you an experienced Trial Master File (TMF) professional ready to take the next step in your career? Syneos Health is seeking a highly motivated and skilled TMF Lead I to join our dynamic team. In this role, you will be instrumental in ensuring end-to-end TMF inspection readiness, upholding governance standards, and contributing to the success of our clinical trials. If you have a strong background in Veeva Vault TMF, clinical trial documentation, and a passion for contributing to groundbreaking medical advancements, we encourage you to apply!
About Syneos Health:
Syneos Health is a leading global biopharmaceutical solutions organization, partnering with companies to accelerate their clinical development and commercialization efforts. We are proud to have contributed to 94% of novel FDA approvals over the past 5 years, demonstrating our commitment to innovation and improving patient outcomes. We offer a supportive and inclusive culture, opportunities for professional growth, and a chance to make a real difference in the world of healthcare.
Job Title: TMF Lead I
Location: Hybrid – Hyderabad, Pune, Gurugram, and Salem
Job Responsibilities:
As a TMF Lead I, you will play a vital role in ensuring the accuracy, completeness, and compliance of our Trial Master Files. Your key responsibilities will include:
- Ensuring TMF Inspection Readiness: Oversee and guarantee end-to-end TMF inspection readiness across assigned projects, proactively identifying and addressing potential gaps or issues.
- Implementing TMF Governance and Compliance: Establish and enforce TMF governance standards, policies, and procedures to ensure compliance with regulatory requirements (GCP, ICH) and company guidelines.
- Monitoring TMF KPIs: Track and analyze TMF Key Performance Indicators (KPIs) to identify trends, monitor performance, and initiate corrective/preventive actions to improve TMF quality and efficiency.
- Representing TMF Operations: Serve as a TMF Operations representative during audits and regulatory inspections, effectively communicating TMF processes and addressing auditor inquiries.
- Leading TMF Training and Process Improvements: Develop and deliver TMF training programs, onboarding materials, and process improvements to enhance team knowledge, efficiency, and adherence to best practices.
- Collaborating with Cross-Functional Teams: Work closely with cross-functional teams (clinical operations, data management, biostatistics, etc.), sponsors, and external stakeholders to ensure seamless TMF management and communication.
- Managing TMF Risks and Timelines: Identify and manage TMF risks, escalations, and documentation timelines, proactively addressing challenges and ensuring timely completion of TMF-related activities.
Required Qualifications:
We are looking for a candidate with the following qualifications:
- Bachelor’s degree in Life Sciences or a related field.
- 5+ years of experience in TMF operations within a clinical research environment.
- Minimum 2+ years of experience in a TMF Lead or functional lead role, demonstrating leadership and mentorship capabilities.
- Strong working knowledge of Veeva Vault TMF (highly preferred).
- Experience working in a CRO (Contract Research Organization) or clinical research setting.
- Solid understanding of GCP (Good Clinical Practice) and ICH (International Council for Harmonisation) guidelines.
Additional Skills and Competencies:
The following skills and competencies will further strengthen your profile:
- Excellent documentation, leadership, negotiation, and communication skills.
- Comprehensive understanding of clinical trial operations and regulatory expectations.
- Proven ability to manage multiple projects and timelines effectively.
- Strong analytical and problem-solving skills.
- Ability to work independently and as part of a team.
Why Join Syneos Health?
At Syneos Health, we offer a rewarding and challenging work environment with numerous opportunities for growth and development. Here are just a few reasons to consider joining our team:
- Global Project Exposure: Work on diverse and impactful clinical trials across the globe.
- Career Development and Training: Access comprehensive training programs and leadership development opportunities to advance your career.
- Supportive and Inclusive Culture: Be part of a collaborative and inclusive team where your contributions are valued.
- Total Rewards and Recognition Programs: Enjoy competitive compensation and benefits packages, along with recognition for your achievements.
- Hybrid and Flexible Working Models: Benefit from flexible working arrangements that promote work-life balance.
Work Location:
This position offers a hybrid working model, with opportunities to work from our offices in:
- Hyderabad
- Pune
- Gurugram
- Salem
Application Instructions:
If you are a highly motivated and experienced TMF professional looking for a challenging and rewarding career opportunity, we encourage you to apply! Please submit your resume and cover letter through our online application portal.