Qureos Mentor

Generate Biomedicines

<div>The Role:

We are seeking a dedicated Senior eTMF Specialist who supports sponsor-side eTMF operations and CRO oversight activities for assigned clinical studies. This role is responsible for execution of 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.

Here's how you will contribute:
<ul>
<li>Serve as primary eTMF contact for studies, ensuring questions related to eTMF items are addressed in a timely manner.</li>
<li>Manage the quality control/completeness of TMF documents according to GCP and regulatory requirements from study start-up to study closeout/archival and preparation for inspections.</li>
<li>Collaborate with internal and external stakeholders (e.g. CRO, Partners) in the management of eTMF related activities, including but not limited to monitor TMF inventory lists, EDLs, metrics, periodic TMF reviews according to study-specific TMF plans, oversee KPIs, and identify areas for improvement.</li>
<li>Provide TMF guidance to study teams based on established processes</li>
<li>Support training on TMF expectations as needed</li>
<li>Provide input on TMF related Work Instructions, SOPs, and tools.</li>
<li>Support TMF elements of regulatory inspections by providing relevant documents and responses as needed.</li>
<li>May support inspection preparation activities as needed</li>
</ul>
CRO/Vendor Oversight
<ul>
<li>Support oversight of CRO/vendor-managed TMFs through regular reviews and follow-ups</li>
<li>Track TMF-related issues, action items, and ensure timely resolution with CROs</li>
<li>Participate in TMF review meetings and provide updates on status and risks</li>
<li>Escalate risks, delays, or quality concerns to the Associate Director as appropriate</li>
<li>Assist in reconciliation activities between sponsor and CRO TMFs</li>
</ul>
The Ideal Candidate will have:
<ul>
<li>BSc required in a biomedical, life science, or related field of study
</li>
<li>Minimum of 4 years' industry experience in supporting the operations of clinical studies, including duties related to TMF Operations oversight.</li>
<li>Proficiency with TMF, GCP and eTMF systems.</li>
<li>Expertise in Veeva Vault system (e.g., eTMF).</li>
<li>Must have TMF experience working at a sponsor company and not only CRO environment.</li>
<li>Understanding of DIA TMF reference model and cross-functional clinical processes.</li>
<li>Demonstrated experience or knowledge with the clinical research process, including the collection of documents at study start-up, during study conduct and close-out.</li>
<li>Demonstrated understanding of TMF related ICH/GCP guidelines.</li>
<li>Familiarity with the management of global clinical trials, clinical trial documents and the TMF document management process.</li>
<li>Experience with the Veeva electronic trial master file system(s) including uploading, reviewing, quality checks (QC), and approval of study required documents.</li>
</ul>
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&mdash;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 &amp; 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. 


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Senior eTMF Specialist

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Generate Biomedicines

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Senior eTMF Specialist