Key Responsibilities
The Manager Clinical Data Management will be responsible for performing/overseeing outsourced (and in-house) Data Management activities as the Lead Clinical Data Manager, to support Immunocore clinical trials worldwide. He/she will participate as an active member of a multi-disciplinary team to assist with executing the Data Management tasks required for phase 1-4 studies, study oversight and general data and document management. They will have a broad fundamental knowledge of the data management process and is able to perform key responsibilities independently and/or with minimal guidance.
Key Responsibilities:
Manage and monitor the progress of data management activities with CRO(s) or other vendors on assigned studies; build effective relationships with CRO / vendor counterparts.
Ability to manage track and oversee CRO responsibilities for overall performance management and provide updates to Head of Data Management.
Ability to guide and influence team members on data management principles and database management principles, vision and strategy
Able to perform independently and/or oversee and be accountable for Data Capture (EDC) systems testing, upgrades, migrations, report production and query management and or CRO (in collaboration with lead data manager) according to company standards.
Participate in clinical study teleconferences and in person meetings to represent data management and provide respective study updates.
Review protocol(s) to ensure appropriate data points are captured within the electronic Case Report Forms (eCRFs) for study conduct, metric development, and trend monitoring in support technology.
Develop and review transfer agreement (DTA/DTS)
Ability to creating, update, and issue data management study specific documentation in line with study activities.
Manage study build process including writing , proofing and assisting with data build specifications.
Extract and analyze clinical data using data visualization tools, SAS data listings and or other outputs regularly to identify trends and/or issues to be communicated and addressed with CRO to support IMC study oversight of CRO activities for regulatory compliance.
Ability to manage and implement new data management processes, guidelines and SOPS within your study team and organization.
Manage, participate and be accountable for the work responsibility deliverables of the assigned DM study team.
Submit and manage study escalations related to poor vendor performance.
Ability to provide site and/ or study team training.
Develop, deploy and manage a be accountable for EDC timelines for milestone data deliveries
Oversee study review practices for study team adherence.
Assist/Own department management and process development of data review and export tools.
Assist/Own department with development of standards (processes, database, system etc.)
Interact with CRO(s), CRAs, programmers, study managers, statisticians, and any other designated key contributors during all phases of conduct of a study to meet defined department goals.
Able to review and provide feedback to CROs or study team on other study related documents related to or that have impact to data management related activities. (e.g. Clinical Monitoring plans, Statistical analysis plans and third party data transfer specs etc.)
Able to review and provide feedback on STDM datasets, formats, mapping
May aid or provide training to internal study team members on Agiloft and/or Netsuite processes
Responsible for department processing of contracts and invoices
Perform occasional data review activities of clinical data and/or external data, to help support lead data manager in high quality oversight of data cleanliness and associated activities
Lead the data management oversight of the TMF, with the CTM, maintenance of data management files and perform consistent quality checks of the TMF to ensure data management related documents are filed in a timely manner to maintain regulatory compliance.
Assist in the database lock and freeze activities per SOPs and timelines
Develop or assist with the development of workflow processes and work instructions, improving the efficiency of data management activities at IMC
Other duties as assigned
Education, Experience and Knowledge:
Education & Qualifications
BA/BS, preferably in the scientific/healthcare field.
At least 5 years of directly relevant work experience
Experience & Knowledge
Significant track record in Data Management for the pharmaceutical/biotechnology industry, or CRO, as a Lead Clinical Data Manger
Has good project management skills and a proven ability to multitask
Understands the scope and focus of Phase 1-4 clinical studies and has a proven ability to perform most of the core Data Management tasks and interact with vendors.
Possesses a comprehensive understanding of regulatory guidelines and industry standards (e.g., ICH/FDA guidance, CDISC standards, GCDMP, 21 CFR 11, MedDRA, WHO Drug Dictionaries, etc.) and their application to Data Management practice.
Attention to detail and the ability to work independently and/ or within a multi-disciplinary team, as well as with external partners and vendors.
Experience and understanding of the Oncology therapeutic area and with Phase III and/or Pivotal studies are preferred.
Possesses solid computer system and technical skills with a strong ability to learn multiple computer applications. Prior experience with different Data Management systems and technologies, and Electronic Data Capture systems. Experience with Medidata RAVE is preferred.
US Salary Range:
$107,250 to $178,750
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.
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 another 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 characteristic protected by law.
