- Novo Nordisk Inc. (Plainsboro, NJ)
- … clinical programs. The Senior CPM will be responsible for all aspects of clinical trial management including execution of clinical trials from protocol ... with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical...assist with periodic audit of the TMF Drive critical clinical trial activities including trial … more
- Genmab (Plainsboro, NJ)
- …as Clinical Drug Supply Manager, of the following tasks:Global Clinical Drug Supply Project/ Trial ManagementObtain Project/ Trial specific information ... possible mitigations (contingency plans and new/additional scenarios) that may impact clinical drug supply)Create and maintain program/project and trial IMP/AMP… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs and patient ... FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved....is preferred A minimum of 12 years' progressively responsible clinical trial experience with at least 10… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the CRO and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and share with study team, ... will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in...the study and propose mitigation plans.Monitor study budget against trial progress and bring deviations to the Operational program… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …medical input regarding country feasibility. Consulted on decisions related to clinical trial feasibility and contributes to the site feasibility ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Genmab (Plainsboro, NJ)
- …Planning and Operational ExecutionOversee strategic and operational plans for clinical trial drug supply.Maintain agreements, contracts, and SOPs ... the pharmaceutical or biopharmaceutical industry.Broad and Diverse experience in working with trial management for global clinical drug supply and supply… more
- Genmab (Plainsboro, NJ)
- …you will play a pivotal role in ensuring the timely delivery of high-quality clinical trial supplies for both early and late-stage trials. In addition, this ... others.You will join a highly competent global team focused on packaging and labeling clinical trial supplies, collaborating closely with the Global Clinical … more
- Genmab (NJ)
- …and processes support the efficient and effective execution of clinical trials.Ensures trial related data management activities (including planning, data ... to the effective planning, and timely delivery of complete, high quality and reliable clinical trial data. The Associate Director DM will provide oversight to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: Senior clinical operational leader accountable for operational planning and execution of FIH, ... clin pharm patient studies, and Phases 1-3 clinical trials at the study and program level. Responsible...start up, and monitor the overall agreed budget against trial progress. Work closely with internal and external stakeholders… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development, effective execution of CMR foundational and role-specific/technical training (eg clinical trial -related, GxP, Compliance, etc.) across the US and ... the strategy, development, effective execution of CMR role-specific/technical training (eg clinical trial -related, patient safety, therapeutic area leads, MSLs… more
