eTMF Specialist at Relay Therapeutics

Cambridge, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

13 Apr, 26

Salary

97000.0

Posted On

13 Jan, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Detail-Oriented, Solution-Oriented, TMF QC Processes, ICH-GCP, FDA Regulations, EMA Regulations, CDISC TMF Reference Model, Veeva Vault eTMF, Organizational Skills, Critical Thinking, Communication Skills, Problem-Solving, Attention to Detail, Quality Management, Process Improvement, Stakeholder Engagement

Industry

Biotechnology Research

Description

The Opportunity: As the TMF Specialist, you will be responsible for working across clinical study teams in line with TMF processes across the development portfolio, with regards to the filing and maintenance activities for clinical studies during the study start-up, maintenance and close-out periods. To be successful, you will be detail-oriented, with a flexible and solution-oriented outlook and the ability to support team members within Relay Therapeutics and with our CRO partners under the guidance of the Sr. Manager, eTMF. Your Role: 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. Your Background: You have 2-5 years industry experience with TMF/eTMF. You have hands-on experience with TMF QC processes, including both individual document quality checks and TMF completeness reviews. You have working knowledge of ICH-GCP, FDA, and EMA regulations. You have working knowledge of the CDISC TMF Reference Model. Veeva Vault eTMF experience a plus. You are a motivated self-starter who has demonstrated critical thinking skills. You have excellent organizational skills with the ability to multi-task and prioritize effectively in an extremely fast-paced and dynamic environment. You have outstanding verbal and written communication skills, allowing for an open and effective dialogue throughout the organization. You have a strong work ethic, excellent problem-solving ability, and attention to detail and quality are critical to success. Estimated Salary Range: [$68,000 - $97,000]. The range provided above is based on what we believe to be a reasonable estimate for this job at the time of posting. Actual base salary will depend on a number of factors, including but not limited to, a candidate’s education, experience, skills and location. #BP1 About Relay Therapeutics Relay Therapeutics is a clinical-stage precision medicines company transforming the drug discovery process with the goal of bringing life-changing therapies to patients. Built on unparalleled insights into protein motion and how this dynamic behavior relates to protein function, we aim to effectively drug protein targets that have previously been intractable, with an initial focus on enhancing small molecule therapeutic discovery in targeted oncology. Our Dynamo platform integrates an array of leading-edge experimental and computational approaches to provide a differentiated understanding of protein structure and motion to drug these targets. We have built a world-class team of leading experts from each of these disciplines, and they are driven by a deep collaboration at every step of our drug discovery process. Our team is equal parts fearless and relentless, with a shared passion for working collaboratively in intellectually stimulating environments. If you’re excited by the challenge of putting protein motion at the heart of drug discovery and passionate about making a difference in the lives of patients, join us!

Responsibilities

The eTMF Specialist will manage TMF processes across clinical study teams, ensuring proper filing and maintenance during study phases. They will also assess eTMF metrics, facilitate TMF QC reviews, and engage with CROs to define responsibilities.