Immunocore
Associate Director of Strategic TMF Operations and Clinical Operations Analytics
Immunocore, Gaithersburg, Maryland, us, 20883
Associate Director of Strategic TMF Operations and Clinical Operations Analytics
This is an onsite position and can be located at either our Gaithersburg, MD or Conshohocken, PA site. The Associate Director of Strategic TMF Operations and Clinical Operations Analytics is a vital member of the Clinical Operations Leadership Team within the Clinical Science and Medical Affairs organization. This role provides strategic leadership and oversight of Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality. The ideal candidate will possess TMF system and process expertise, exceptional vendor oversight, and a strong foundation in inspection readiness and support. Beyond TMF responsibilities, this position oversees Clinical Operations reporting, metrics, KPIs, and analytics. The role involves collaborating with senior leaders and key stakeholders to establish, manage, and generate reports and analytics that support performance measurement, delivery optimization, and continuous improvement. Key Responsibilities
TMF Operations: Accountable for the company’s Trial Master File support model, processes, and systems. Responsible for oversight and management of TMF vendors and associated processes for the TMF. Develop and oversee global TMF-related standards, standard operating procedures (SOPs), and corresponding controlled documents that are in line with relevant regulations and industry best practices. Provide expertise and strong leadership to ensure inspection readiness and facilitate seamless support of audits and regulatory inspections. Experience & Knowledge
Essential: Advanced understanding of ICH-GCP, and regulatory requirements as they apply to the Trial Master File. Previous experience in document management and electronic TMF systems (e.g., Veeva Vault, Wingspan, Trial Interactive, Documentum, etc.). Extensive experience with Veeva Vault and the suite of Veeva applications is strongly preferred. Capable of developing, executing, and assessing strategies to enhance processes and set direction in the TMF and Clinical Systems domain. Education & Qualifications
BA or Bachelor of Science, in science-related field (biological science, medical, pharmacy, or other health-related discipline), or equivalent clinical research (or related) experience. Advanced degree preferred. At least 10 years relevant clinical research (or related) experience in a biotechnology/pharmaceutical industry and/or clinical research organization in Clinical Operations and/or a focus on Clinical Systems and/or Trial Master File/Clinical Document Management. Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
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This is an onsite position and can be located at either our Gaithersburg, MD or Conshohocken, PA site. The Associate Director of Strategic TMF Operations and Clinical Operations Analytics is a vital member of the Clinical Operations Leadership Team within the Clinical Science and Medical Affairs organization. This role provides strategic leadership and oversight of Trial Master File (TMF) operations, enhancing functionality, efficiency, scalability, and quality. The ideal candidate will possess TMF system and process expertise, exceptional vendor oversight, and a strong foundation in inspection readiness and support. Beyond TMF responsibilities, this position oversees Clinical Operations reporting, metrics, KPIs, and analytics. The role involves collaborating with senior leaders and key stakeholders to establish, manage, and generate reports and analytics that support performance measurement, delivery optimization, and continuous improvement. Key Responsibilities
TMF Operations: Accountable for the company’s Trial Master File support model, processes, and systems. Responsible for oversight and management of TMF vendors and associated processes for the TMF. Develop and oversee global TMF-related standards, standard operating procedures (SOPs), and corresponding controlled documents that are in line with relevant regulations and industry best practices. Provide expertise and strong leadership to ensure inspection readiness and facilitate seamless support of audits and regulatory inspections. Experience & Knowledge
Essential: Advanced understanding of ICH-GCP, and regulatory requirements as they apply to the Trial Master File. Previous experience in document management and electronic TMF systems (e.g., Veeva Vault, Wingspan, Trial Interactive, Documentum, etc.). Extensive experience with Veeva Vault and the suite of Veeva applications is strongly preferred. Capable of developing, executing, and assessing strategies to enhance processes and set direction in the TMF and Clinical Systems domain. Education & Qualifications
BA or Bachelor of Science, in science-related field (biological science, medical, pharmacy, or other health-related discipline), or equivalent clinical research (or related) experience. Advanced degree preferred. At least 10 years relevant clinical research (or related) experience in a biotechnology/pharmaceutical industry and/or clinical research organization in Clinical Operations and/or a focus on Clinical Systems and/or Trial Master File/Clinical Document Management. Immunocore is proud to be an equal opportunity employer. As such, we are committed to fostering an inclusive workplace where everyone feels valued, respected, and empowered. We encourage applications from individuals of all backgrounds, regardless of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, or any other characteristic protected by law.
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