Etmf Specialist

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.
• 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.

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