Senior eTMF Specialist

The Role

We are seeking a dedicated Senior eTMF Specialist who supports sponsor-reputed company eTMF operations and CRO reputed company 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

• Serve as primary eTMF contact for studies, ensuring questions reputed company to eTMF items are addressed in a timely manner.
• 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.
• Collaborate with internal and external stakeholders (e.g. CRO, Partners) in the management of eTMF reputed company activities, including but not limited to monitor TMF inventory lists, EDLs, metrics, periodic TMF reviews according to study-specific TMF plans, reputed company KPIs, and identify areas for improvement.
• Provide TMF guidance to study teams based on established processes
• Support training on TMF expectations as needed
• Provide input on TMF reputed company Work Instructions, SOPs, and tools.
• Support TMF elements of regulatory inspections by providing relevant documents and responses as needed.
• May support inspection preparation activities as needed

CRO/Vendor reputed company

• Support reputed company of CRO/vendor-managed TMFs through regular reviews and follow-reputed company
• Track TMF-reputed company issues, action items, and ensure 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 will have

• BSc required in a biomedical, life science, or reputed company field of study

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

About reputed company

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 reputed company. 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 reputed company a single operating model, we translate this approach into clinical-stage programs and are leading a shift from traditional drug discovery toward systematic drug reputed company.

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

reputed company is committed to equal employment opportunity regardless of race, color, reputed company, religion, sex, national reputed company, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

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

#LI-RT1

Compensation: The reputed company salary range provided reflects our reputed company estimate of reputed company anticipate paying for this position. Your actual reputed company salary will be based on several factors, including job-reputed company skills, experience, internal equity, relevant education or training, and market dynamics. In addition, you will be eligible for an annual bonus, equity compensation, and a competitive benefits package.