Senior eTMF Specialist

About the Role:

We are seeking a dedicated Senior eTMF Specialist to support sponsor-side eTMF operations and CRO oversight activities for assigned clinical studies. This role is responsible for executing TMF management activities, ensuring TMFs are inspection-ready, complete, and compliant. The position works under the guidance of the Associate Director and focuses on operational delivery.

Key Responsibilities:

• Serve as the primary eTMF contact for studies, addressing questions related to eTMF items promptly.
• Manage the quality control and completeness of TMF documents according to GCP and regulatory requirements from study start-up to closeout/archival and inspection preparation.
• Collaborate with internal and external stakeholders (e.g., CRO, Partners) on eTMF activities, including monitoring TMF inventory lists, EDLs, metrics, periodic TMF reviews, overseeing KPIs, and identifying improvement areas.
• Provide TMF guidance to study teams based on established processes and support training on TMF expectations.
• Contribute to TMF-related Work Instructions, SOPs, and tools.
• Support TMF elements of regulatory inspections by providing relevant documents and responses.
• May assist in inspection preparation activities.

CRO/Vendor Oversight:

• Support oversight of CRO/vendor-managed TMFs through regular reviews and follow-ups.
• Track TMF-related issues and action items, ensuring timely resolution with CROs.
• Participate in TMF review meetings and provide updates on status and risks.
• Escalate risks, delays, or quality concerns to the Associate Director as appropriate.
• Assist in reconciliation activities between sponsor and CRO TMFs.

The Ideal Candidate:

• BSc required in a biomedical, life science, or related field of study.
• Minimum of 4 years of industry experience supporting clinical study operations, including TMF Operations oversight duties.
• Proficiency with TMF, GCP, and eTMF systems.
• Expertise in Veeva Vault system (e.g., eTMF).
• Must have TMF experience working at a sponsor company, not solely in a CRO environment.
• Understanding of the DIA TMF reference model and cross-functional clinical processes.
• Demonstrated experience or knowledge of the clinical research process, including document collection at study start-up, during study conduct, and close-out.
• Demonstrated understanding of TMF-related ICH/GCP guidelines.
• Familiarity with managing global clinical trials, clinical trial documents, and the TMF document management process.
• Experience with Veeva electronic trial master file system(s), including uploading, reviewing, quality checks (QC), and approving study-required documents.

About Generate Biomedicines:

We are a clinical-stage generative biology company pioneering the AI revolution in drug design and development. We are advancing a new approach to drug creation—one grounded in the ability to design proteins with defined biological intent. By integrating machine learning with large-scale experimentation, this approach aims to reduce the uncertainty, time, and cost associated with developing protein-based medicines.

Founded in 2018, we are advancing a growing pipeline of clinical and preclinical programs across multiple disease areas and protein modalities. By unifying computational design and clinical development within a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug generation.

At Generate:Biomedicines, we collaborate across disciplines in new ways to invent and innovate. We bring diverse perspectives to a shared goal of delivering better medicines to patients in need, faster, guided by our values and leadership behaviors.

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

Key skills/competency:

• eTMF Specialist
• TMF Management
• GCP Compliance
• Veeva Vault
• Clinical Study Operations
• Regulatory Inspections
• CRO Oversight
• ICH/GCP Guidelines
• DIA TMF Reference Model
• Drug Development