Location: Cambridge MA
Job Code: Job Req: JULCL21
Clinical Trial Manager, Clinical Operations sought by biopharmaceutical company in Cambridge, MA.
Cambridge, MA.-based H3 Biomedicine (https://www.h3Biomedicine.com/) is a leading company in cancer genomics based drug discovery, delivering on the promise of precision medicine. The company was launched in 2011 with an unprecedented $200 million in initial funding from Eisai, plus a continued ongoing commitment to fund H3’s robust discovery pipeline and clinical programs. Now with four clinical stage anti-cancer molecules in active development, H3 is able to uniquely leverage distinct insights from cancer genomics and real-life patient data to advance its projects to clinical proof of concept and beyond. H3 embraces a novel business model in which it collaborates with Eisai, a leading global pharmaceutical company, to create a prolific drug discovery engine and partnership platform.
Principal Duties and ResponsibilitiesResponsible for:
- orchestrating clinical operations activities across a compound under development, and managing day-to-day study operations for one or more clinical studies to meet individual clinical trial objectives and corporate goals;
- oversee all aspects of global and domestic clinical trials predominantly run through CROs to ensure delivery of company goals on time, within budget, and in compliance with SOPs and FDA and ICH/GCP guidelines;
- represent and lead the study team to ensure successful clinical trial planning, design, execution and delivery within specified quality, time and cost parameters;
- oversight of CROs and other clinical vendor activities; accountable and responsible for compliance and quality management of clinical trials;
- participate in the development and review of key documents for the support of clinical trial execution including protocols, oversight plans, case report forms, and other study management plans;
- develop and manage clinical trial financial agreements including study budgets, service contracts, and investigator grants;
- lead the development and implementation of clinical operations SOPs and work instructions.
- Remains current in relevant product and professional areas of interest; monitor the status of clinical data, including third party data to enable timely lock of data bases.
- Master’s degree (or foreign equivalent degree) in Pharmaceutical Science, Project Management, Pharmacy, or closely related field
- plus 2 years of industry experience in job offered or as Clinical Research Associate/Clinical vendor Specialist in a pharmaceutical development and clinical trial management setting.
- Also requires 2 years of oncology clinical operations experience in the following (which may have been gained concurrently):
- Management of multi-center regional clinical trials (MCRT) form initiation through close-out;
- With GCP, clinical trial design, regulatory processes, and global clinical development process and clinical compliance and inspection readiness;
- Electronic Data Capture and CTMS concepts, Trial Master File applications and IRT systems, clinical databases, IVRS systems, and Microsoft Visio.
About H3 Biomedicine Inc.
H3 Biomedicine Inc. is a privately-held, uniquely-structured oncology discovery enterprise whose sole mission is to become a prolific source of new drugs that treat more human cancers with greater success. H3 Biomedicine is applying the expertise of leading scientists to the integration of insights from cancer genomics with innovative capabilities in synthetic chemistry and tumor biology to pursue the most promising current opportunity in cancer therapeutics: patient-based, genomics-driven, small molecule drugs.