- Daiichi Sankyo, Inc. (Bernards, NJ)
- …planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in ... on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking...teams and tracking CRO and other vendor performance against project goals and milestones to monitor and ensure compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- Position Title: Senior Biostatistician Join a Legacy of Innovation 125 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply of innovative ... and leads/contributes to internal statistical workstreams to address various project needs. The position works closely with contract research organization… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and the RA team and serves ... as ad hoc member to the Global Project Team for late stage projects. This position manages...technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with stakeholders across Clinical Medical and Regulatory (CMR), including the NACO senior leadership team and line of business management team, as well as the ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...in cross-functional teams locally/globally to assure timely attainment of project milestones Develops solutions for process improvements; enhance quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position The HEOR Strategy and Evidence Synthesis Manager will be part of the HEOR Evidence Synthesis...sub-team. The HEOR-ESS sub-team is part of a larger Clinical Data Science and Evidence (CDSE) team which sits… more
- Novo Nordisk Inc. (Boulder, CO)
- …activities. The Manager of Drug Product Manufacturing is accountable for clinical phase 1 and 2 drug product manufacturing and will have thorough knowledge ... aspects of drug product manufacturing operations at CMOs to manufacture clinical parenteral medicines according to approved protocols, regulations, and timelines… more
- SSM Health (Madison, WI)
- …WI-SSM Health West Beltline **Worker Type:** Regular **Job Highlights:** This is a full time Senior Project Manager role that will be onsite at the Wisconsin ... in Madison with some travel required to the local hospitals and clinics. Project management experience related to medical group operations and risk management is… more
- ZOLL Medical Corporation (Minnetonka, MN)
- …single- and multi-center studies both inside and outside of the United States. The Senior Clinical Project Manager collaborates with internal teams, ... experience in medical device industry required + 5+ years of Clinical Project Management experience required + Medical device experience with Class III… more
- Catalyst Clinical Research LLC (NC)
- As a Senior Project Manager - Oncology,...laboratory technology. Experience: 7 years previous experience in a Project Manager role in a clinical ... FDA regulations, ICH GCP guidelines, and their application to clinical trials. + Excellent written, oral communication and presentation...Investigator Meetings as needed. May need support from a Senior Project Manager . + Lead… more
- United Therapeutics (Silver Spring, MD)
- …diseases, and other orphan diseases. **How you'll contribute** Experienced and hands-on Project Manager , working alongside the Head of Program Management to ... as manage program timelines and key milestones and transmit project /study metrics to senior management. This is...scientific discipline (life sciences preferred) + 5+ years of clinical project management experience in the pharmaceutical,… more
