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Immunocore · 2 days ago

Associate Director, TMF Operations and Clinical Operations Analytics

Radnor, PA

Full-time

Onsite

Lead/Staff, Director/Executive

10+ years exp

Immunocore is a pioneering biotechnology company focused on developing transformative medicines for oncology and other diseases. The Associate Director of TMF Operations and Clinical Operations Analytics will provide strategic leadership in TMF operations and oversee reporting and analytics within Clinical Operations, ensuring compliance and effectiveness in performance measurement.

BiotechnologyHealth CareMedicalPharmaceutical

Responsibilities

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

Primary point of contact related to TMF processes and systems and study specific TMF support, as appropriate

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 inspections

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 resolution

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, CDMS/EDC)

Lead governance committee with TMF Vendors

Create and generate sophisticated reporting, metrics/KPIs and other analytics that can be used to measure performance, compliance, and effectiveness

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 opportunities

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 and 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 reporting

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 objectives

Responsible for ensuring appropriate operational training for staff members

Identification of high-performance team members and working on team development

Qualification

TMF operations expertiseClinical Operations analyticsVendor managementRegulatory compliance knowledgeVeeva Vault experienceClinical trial metricsProject management skillsCommunication skillsTime management skillsProblem-solving abilities

Required

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.)

Capable of developing, executing, and assessing strategies to enhance processes and set direction in the TMF and Clinical Systems domain

Proficient in identifying, understanding, and mitigating risks, while ensuring effective communication of these risks to clinical 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 trial metrics

Extensive experience in oversight and management of vendors

Highly experienced in business ownership of reporting tools used to compile standard clinical trial metrics as well as generate ad-hoc 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 team matrices

Extensive 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

A commitment to producing high-quality work with an attention to detail

Demonstrated ability to problem solve and use clear judgement in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical studies

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

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

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)