Clinical Data Manager
Conshohocken, Pennsylvania, United States
Clinical Data Manager
Conshohocken, PA or Rockville, MD
Immunocore is a late-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies designed to treat a broad range of diseases, including cancer, infection and autoimmune disease. We are developing a deep pipeline in multiple therapeutic areas, including five clinical stage programs in oncology and infectious disease, advanced pre-clinical programs in autoimmune disease and multiple earlier pre-clinical programs.
It is an exciting time to join Immunocore. Our most advanced oncology therapeutic candidate, tebentafusp, has demonstrated an overall survival benefit in a randomized Phase 3 clinical trial in metastatic uveal melanoma, a cancer that has historically proven to be insensitive to other immunotherapies. The company also recently completed its Initial Public Offering and was listed on the NASDAQ.
The Clinical Data Manager will be responsible for performing/overseeing outsourced Data Management activities that support Immunocore clinical trials worldwide. He/she will participate as an active member of a multi-disciplinary team to plan, lead and execute the Data Management tasks required for phase 1-4 studies. The Clinical Data Manager has a broad, fundamental knowledge of the data management process and the regulatory guidelines as it pertains to the clinical data manager role and is able to perform most required tasks with minimal guidance.
This position is located in Conshohocken, PA or Rockville, MD.
Experience & knowledge
- Minimum 3 years’ experience as a Lead Clinical Data Manager and/or minimum 5 years’ experience as a Clinical Data Manager support with increasing study responsibility
- Proficiencies with EDC preferably Medidata RAVE or Oracle CDMS
- Significant experience working with and management of CROs
- Significant track record in Data Management for the pharmaceutical/biotechnology industry, or CRO, including study lead experience.
- 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 practices.
- Ability to comfortably apply regulatory guidelines without guidance.
- Attention to detail and the ability to work individually, 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 InForm and Rave is preferred.
- BA/BS, preferably in the scientific/healthcare field.
Lead with Science and Discover What is Within:
- We value Entrepreneurship and Diversity
- Respect, Trust, and Integrity
- Competitive compensation
- Medical and vision benefits, beginning your first day of employment
- Fully paid Dental Insurance
- 20 days’ vacation plus holidays
- Fully paid Life Insurance and Disability
- 401(k) with Company Match
Candidates must be eligible to work in the U.S. without company sponsorship, now or in the future, for employment-based work authorization. F-1 visa holders with Optional Practical Training (OPT) who will require H-1B status, TNs or current H-1B visa holders will not be considered. H1-B and green card sponsorship is not available for this position.
Immunocore is an E-Verify employer.