Senior Manager - Trial Master File, Clinical Operations
Immunocore

Job Info

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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 autoimmune diseases.

We strive to create a diverse and inclusive workplace, while seeking talented individuals to work with us across the many functions that will allow us to deliver new medicines to transform the lives of patients. You will work with outstanding people who together pioneer the research, development and commercialization of bi-specific TCR therapies. We aim to create an environment where individual contributions and initiatives can be maximized, while fostering a culture of collaboration, based on respect and integrity. We want each individual employee to own their career, as part of high-performing teams, and in the context of on-the-job and formal continuous development and training, as well as constructive feedback. We always strive to identify ways to improve what we do and how we do it, by asking questions, voicing opinions, exploring various approaches and staying connected with healthcare professionals, patients, academia and other key partners.
Key Responsibilities
The Sr. Manager, Trial Master File will be accountable for the company's Trial Master File support model, processes and systems and to oversee the Trial Master File group, including direct line management of TMF staff. This role is onsite and can be based in either Rockville, MD, or Conshohocken, PA. They will also be responsible for ensuring TMF staff work with the cross functional teams (including third party vendors) to ensure the relevant study TMFs are maintained and delivered according to governing regulations and procedures. They will provide strategic leadership, stakeholder management, and comprehensive oversight of key vendors that support the process. They will also provide significant support to audit and regulatory inspection-related activities.

KEY RESPONSIBILITIES
* Accountable for the company's Trial Master File support model, processes and systems
o 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, CDMS/EDC).
o Responsible for oversight and management of TMF vendors and associated processes for the TMF
o Primary point of contact related to TMF processes and systems and study specific TMF support, as appropriate.
* Develop and oversee global 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).
* Review and provide expert TMF operations input into clinical documents as it relates to TMF in the study plans.
* Develop, generate, analyse, and present to leadership standard TMF metrics/KPIs to demonstrate TMF health.
* Lead the development, 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 resolution.
* Drive stakeholder management with key partnering functions and raise broader organizational TMF awareness, ensuring appreciation of TMF strategy and value.
* Collaborate with cross-functional counterparts to oversee the performance for all TMF activities to deliver programs on time and with quality.
* Provide expertise and strong leadership to ensure inspection readiness and facilitate seamless support of audits and regulatory inspections.
* Support efforts for the selection and oversight of external service providers, including Contract Research Organizations (CROs) and other vendors as necessary.
* Identifies and communicates TMF related study issues that will impact budget, resources, and timelines. Provides support/escalation point for TMF personal as needed.
* Participates and/or Leads governance committee with TMF Vendors

OTHER DUTIES
* Leads and/or contributes to department initiatives and assists in the design and implementation of standardized work processes.
* Supports and participate in request and review of scope of works, budgets, vendor performance and issue resolution.
* Support development, review, and/or approval of study specific TMF management plans and associated indexes in collaboration with IMC internal and external (third party vendor) functional/sub-functional area study team members, as needed.

SUPERVISORY RESPONSIBILITY
* Effectively manage resources to ensure appropriately skilled and high performing staff members are assigned to s support the effective execution of the TMF portfolio and achieve department objectives.
* Responsible for ensuring appropriate operational training for staff members.
* Identification of high-performance team members and working on team development

Experience & knowledge
Essential
* Advanced understanding of ICH-GCP, and regulatory requirements as they apply to the Trial Master File
* Advanced end-to-end understanding of clinical trial phases involved in drug development and corresponding document requirements.
* Previous experience actively supporting audits and regulatory inspections.
* Previous experience in document management and electronic TMF systems (e.g., Veeva Vault, Wingspan, Trial Interactive, Documentum, etc.)
* Previous experience implementing off-the-shelf eTMF systems and associated processes is required.
* Ability to work independently with minimal supervision and within global, cross-functional team matrices.
* Experience in oversight and management of vendors
* Experience in managing people and/or contracted resources.
* Knowledge and familiarity with industry workgroups and initiatives such as DIA Records Management Community (TMF Reference Model)
* Excellent written and oral communication skills and strong interpersonal skills
* Possesses excellent time management and organization skills.
* Demonstrated ability to problem solve and use clear judgement in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies.

Desirable
* Experience with other clinical systems preferred (e.g., CTMS, document management systems, etc.).
* Experience in developing implementing inspection readiness processes and tools
* Prior experience with Veeva Vault eTMF and/or other Veeva products
* Additional knowledge of and experience with regulatory requirements (BLA/MAA submissions) and quality systems 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 related) experience. Advanced degree preferred.
* At least 8 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 Trial Master File/Clinical Document 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)
 
A valid passport is required for this role. Some international and local travel maybe required, approximately up to 20 % travel.

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