Relay Therapeutics · 21 hours ago
eTMF Specialist
Cambridge, MA
Full-time
Onsite
Entry, Mid Level
$68K/yr - $97K/yr
2+ years expRelay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process. The TMF Specialist will be responsible for overseeing TMF processes across clinical study teams, ensuring compliance and quality in clinical study documentation throughout the study lifecycle.
BiotechnologyHealth CareTherapeutics
Responsibilities
You will engage in assessing eTMF metrics for completeness, timeliness, and quality
You will facilitate TMF QC Reviews and ensure issues identified are tracked to resolution
You will help build and maintain strong partnership with key stakeholders to ensure cross-functional eTMF engagement
You will engage with CROs/Vendors to ensure responsibilities around eTMF are clearly defined and executed
You will contribute to eTMF study creation, maintenance, and archival, ensuring all activities are performed in accordance with Relay’s Standard Operating Procedures (SOPs), ICH-GCP Guidelines, EMA, FDA, and other health authority requirements
Applies risk-based quality management (RBQM) principles to Trial Master File (TMF) oversight, ensuring proportionate review, inspection readiness, and regulatory compliance
You will help identify business needs to assess the current state of eTMF and identify opportunities for process improvement, ensuring industry best practice is implemented
You will participate in the creation and review of Study-specific eTMF Plans, Study-specific TMF Indexes, and QC approach across all studies
You will participate in discussions with IT and eTMF system managed services relations and topics
You may participate in health authority inspections and audits
Qualification
Required
2-5 years industry experience with TMF/eTMF
hands-on experience with TMF QC processes, including both individual document quality checks and TMF completeness reviews
working knowledge of ICH-GCP, FDA, and EMA regulations
working knowledge of the CDISC TMF Reference Model
motivated self-starter who has demonstrated critical thinking skills
excellent organizational skills with the ability to multi-task and prioritize effectively in an extremely fast-paced and dynamic environment
outstanding verbal and written communication skills, allowing for an open and effective dialogue throughout the organization
strong work ethic, excellent problem-solving ability, and attention to detail and quality are critical to success
Preferred
Veeva Vault eTMF experience a plus
Company
Relay Therapeutics
Relay therapeutics is a developer of an allosteric drug-discovery platform intended to apply computational techniques to protein motion.
51-200 employees
H1B Sponsorship
Relay Therapeutics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (7)
2023 (2)
2022 (5)
2021 (6)
2020 (1)
Funding
Current Stage
Public CompanyTotal Funding
$1.4BKey Investors
Nextech InvestSoftBank Vision FundBiotechnology Value Fund
2024-09-10Post Ipo Equity· $200M
2024-01-08Post Ipo Equity· $30M
2022-09-12Post Ipo Equity· $300M
Leadership Team
Sanjiv Patel
President and CEO
Imogen Pryce
Chief Operating Officer, R&D
Recent News
2025-12-16
2025-12-12
Company data provided by crunchbase