- Novo Nordisk Inc. (Plainsboro, NJ)
- …Master File (TMF) and assist with periodic audit of the TMF Drive critical clinical trial activities including trial site activations, recruitment, and ... Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We...pharmaceutical industry Minimum 2 years of experience as a Clinical Trial /Project Manager Experience with global … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure ... Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We...Responsible for all areas related to patient safety in clinical trials Act as member of the trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …matters; Represents Clinical Development in Project Teams, possibly as Global Clinical Lead . ResponsibilitiesStudy Strategy: Clinical study leader (CSL) ... Phase 2 studies: Provides input on major milestones of trial , clinical trial plan and...regularly, Leads dose-escalation meetings, Performs quality assessment with delivery lead eg review TLG before DBL, and quality check… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with facilities in Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We are building for the ... expert who wants to work with innovative investigational medicines. You will lead a global regulatory team to develop and execute regulatory strategies for… more
- Genmab (Plainsboro, NJ)
- …expert supporting the clinical development of compounds as compound and/or indication lead for both early and late-stage programs, and/or as trial ... synopsis, protocols, statistical analysis plans, results meetings presentations and clinical trial reportsCoordinate data transfers from/to business partners… more
- Merck & Co. (Rahway, NJ)
- …Lead research activities for innovative statistical methods and applications in clinical trial development.Collaborates in publication of research results in ... processing software eg SAS and/or R.-Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Excellent oral and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …decisions (phase I trials) Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure ... Cambridge and Seattle reflect the full R&D continuum, from early research through late-stage clinical development. Here,...Responsible for all areas related to patient safety in clinical trials Act as member of the trial… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... for diverse data sets and identifies any erroneous data. Lead Companion Diagnostics data management activities by acting as...disease therapeutic area is a must. Working knowledge of Clinical trial data systems and/or EDC and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Essential Functions Support the VP Medical/Scientific Development as the US/international clinical lead for DCR-PHXC program to both internally and ... Lexington, MA and Plainsboro, NJ. We support programs from early research through late-stage clinical development. We...part in developing the area as well as a lead role in various improvement projects, including process optimization.… more
- Merck & Co. (North Wales, PA)
- …OCAR, and medical affairs leaders.- Ensure incorporation of US commercial input into clinical trial development and global asset strategy development. Shape the ... and go-to-market strategies like positioning, segmentation, and target channel selection. Lead , collaborate and execute early US marketing activities including… more
