Associate Director of Strategic TMF Operations and Clinical Operations Analytics

About the job

Location of role Conshohocken,PA or Gaithersburg, MD

Department Clinical Operation

s
Key Responsibilities This is an onsite position and can be located at either our Gaithersburg, MD or Conshohocken, PA site

s.
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 suppo

rt.
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 improvem

ent.
Key Responsibil

ities
TMF Operations: Accountable for the company’s Trial Master File support model, processes, and s

• ystems
  Responsible for oversight and management of TMF vendors and associated processes for
• the TMFPrimary point of contact related to TMF processes and systems and study specific TMF support, as appro
• priate.Develop and oversee global TMF-related standards, standard operating procedures (SOPs) and corresponding controlled documents that are in line with relevant regulations (e.g., ICH-GCP, and regulatory requirements such as EMA and MHRA) and industry best practices (e.g., CDISC Trial Master File Reference
• Model).Provide expertise and strong leadership to ensure inspection readiness and facilitate seamless support of audits and regulatory inspe
• ctions.Review and provide expert TMF operations input into clinical documents, particularly study
• plans.Develop, generate, analyse, and present to leadership standard TMF metrics/KPIs to demonstrate TMF
• health.Lead the continuous evolution, implementation, and oversight of TMF support
• model.Provide operational leadership to TMF vendor budget negotiations and management of TMF operations
• spend.Lead and manage the relationship with TMF-related vendors, ensuring appropriate contract scope, budgets, vendor performance and issue reso
• lution.Serve as TMF Operations functional area representative for the implementation of any systems or processes that would interface/integrate with TMF (e.g., CTMS, EDMS, ISF, CDM
• S/EDC).Lead governance committee with TMF
• VendorsClinical Operations Reporting and Analytics: Provides technical expertise and leadership to develop and execute Clinical Operations reporting and analytics strategies and initiatives that align with organizational business obje
• ctives.Create and generate sophisticated reporting, metrics/KPIs and other analytics that can be used to measure performance, compliance, and effecti
• veness.Lead interpretation of metrics and analytics to ensure accuracy, aligned stakeholder interpretation, and
• trends.Communicate performance metrics and KPIs to study teams, functional leadership, and senior management, identifying issues, trends, and opportu
• nities.Ensure that portfolio of metrics, reporting and analytics solutions are fit for purpose at Immunocore and are strategically aligned, accurate, scalable, and managed regarding functionality, utilization, and
• budget.Drive ongoing assessment of systems that support analytics and reporting to manage risks an
• d gaps.Provides business oversight across all involved systems to ensure ongoing alignment and proper mapping of data in support of metrics/KPIs and Clinical Operations rep

orting.
SUPERVISORY RESPON

SIBILITY
This position includes staff oversight and may include line manager responsi

• bilities.
  Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to support the effective execution of the TMF portfolio and achieve department o
• bjectives.Responsible for ensuring appropriate operational training for staf
• f members.Identification of high-performance team members and working on team d

evelopment
Experience &

; Knowled

• ge
  Essential
  Advanced understanding of ICH-GCP, and regulatory requirements as they apply to the Tria
• l Master FilePrevious experience in document management and electronic TMF systems (e.g., Veeva Vault, Wingspan, Trial Interactive, Docu
• mentum, etc.)Extensive experience with Veeva Vault and the suite of Veeva applications is strong
• ly preferred.Capable of developing, executing, and assessing strategies to enhance processes and set direction in the TMF and Clinical Sy
• stems domain.Proficient in identifying, understanding, and mitigating risks, while ensuring effective communication of these risks to clinica
• l leadership.Skilled in negotiating and influencing to address high-impact challenges within the TMF and Clinical
• Systems area.Previous experience actively supporting audits and regulatory
• inspections.Advanced experience in creating, generating, and analysing operational clinical t
• rial metrics.Extensive experience in oversight and manageme
• nt of vendorsHighly experienced in business ownership of reporting tools used to compile standard clinical trial metrics as well as generate ad-h
• oc reporting.Advanced end-to-end understanding of clinical trial phases involved in drug development and corresponding document
• requirements.Demonstrates strong leadership and project management abilities, with flexibility and agility in a multi-functional, global matrix
• environment.Ability to work independently with minimal supervision and within global, cross-functional t
• eam matrices.Extensive experience in oversight and manageme
• nt of vendorsExperience in managing people and/or contract
• ed resources.Knowledge and familiarity with industry workgroups and initiatives such as DIA Records Management Community (TMF Ref
• erence Model)Excellent written and oral communication skills and strong interpe
• rsonal skillsPossesses excellent time management and organiz
• ation skills.A commitment to producing high-quality work with an attenti
• on to detail.Demonstrated ability to problem solve and use clear judgement in relation to regulatory requirements, interactions with external parties, timelines, and complex clin

ical stud

• ies.
  Desirable
  Experience implementing and managing a wide range of clinical systems such as CTMS, IRT/RTSM and eCOA/ePRO is hi
• ghly desirable.Experience with data management and biostatistical sys
• tems preferred.Experience in developing implementing inspection readiness proce
• sses and tools.Prior experience with Veeva Vault eTMF and/or other Veeva products is hi
• ghly desirable.Additional knowledge of and experience with regulatory requirements (BLA/MAA submissions) and quality sys

tems preferred.
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 rel
• ated) 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 Doc
• ument Management.Demonstrated computer skills; proven functional knowledge of Microsoft packages (such as but not limited to Microsoft Word, PowerPoint, Project, Excel, SharePoint, Adobe Acrobat) and TMF and/or Document Management applications (

e.g., eTMF, EDMS)
About the Company Immunocore (NASDAQ: IMCR) is a pioneering, commercial-stage T cell receptor biotechnology company whose purpose is to develop and commercialize a new generation of transformative medicines which address unmet patient needs in oncology, infectious diseases and autoimmune disease. Our leaders in R&D are internationally recognised as some of the biotech industry’s most successful drug developers. We are creating not just an environment where great minds can interact but an innovation powerhouse answering

the big questions.
Focused on delivering first-in-class biological therapies to patients, we have developed a highly innovative soluble TCR platform. Our ImmTAX molecules underpin a new generation of precision engineered drugs that harness the immune system to treat a broad spectrum of diseases with high unmet medical need, including oncology, infectious diseases and a

utoimmune diseases.
At Immunocore, we recognize that our employees are our greatest asset. We value the unique contributions each person brings to our team. By embracing Science, Trust, Respect, Integrity, Diversity, and Entrepreneurship (STRIDE), we create an environment where collaboration thrives, ideas flourish, and transformative changes happen. STRIDE represents more than just letters; it embodies our shared identity and drives our mission. We are dedicated to developing breakthrough therapies that transform patients’ lives, advancing medicine, and supporting one anothe

r in these pursuits.
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 characteris