- Novo Nordisk Inc. (Plainsboro, NJ)
- …Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...encore abstracts, reviews, and supplements) in collaboration with Publications Manager Independent Medical Education (IME) Assist in developing medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …scenarios and strategy for all pipeline products starting in Phase II clinical trials. Generates insights to support G3 decision-making Assesses investments in payer ... impacting Novo Nordisk profitability. Proactively drives price sensitivity/price elasticity studies for new and in-line products with resultant break-even elasticity… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory submissions.Advertising and PromotionGain understanding of how prescription drug clinical studies , regulatory strategy, and FDA-approved labeling ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team… more
- Catalent Pharma Solutions (Somerset, NJ)
- …lean supply chains for individual studies or programs + Create initial study drug projections and supply plan for clinical supply needs throughout life ... **Senior Clinical Supplies Manager ** **Position Summary:** Catalent...and Catalent employee.** **The Role:** + Understand and translate clinical study protocol requirements into demand for… more
- Adecco US, Inc. (Princeton, NJ)
- …collaboration with representatives from other functions. The position acts as DM resource to the Clinical Study team and guides the team in the coordination of ... Healthcare and Lifesciences is looking to hire a Lead Clinical Data Manager ** **for their client in...practices. Strong experience leading data management activities for multiple clinical studies , proficient use of data management… more
- Taiho Oncology (Princeton, NJ)
- …to support the creation of relevant high-quality clinical documents such as study protocols and clinical study reports (CSRs), investigator brochures, ... conferences and leverages the knowledge for designing and summarizing clinical studies . + Keeps Sr. Medical Director...as reviewing of the quality of ongoing and final clinical study data, protocols and CSRs, investigator… more
- ThermoFisher Scientific (Lawrenceville, NJ)
- …the Life:** + Oversee and manage the complete lifecycle of biospecimens collected for clinical studies with minimal supervision. + Core Clinical Team member ... samples, loading documents to Shared Drive folders, etc.). + Independently reviews clinical study protocol providing comparison of vendor statement of work… more
- Bristol Myers Squibb (Princeton, NJ)
- … Scientist function provides scientific expertise necessary to design and deliver clinical studies and programs. **Position Summary / Objective** + Will ... study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team...the protocol in collaboration with Data Management/Programming + Submit clinical contributions to clinical study … more
- Bristol Myers Squibb (Princeton, NJ)
- …with the TA Medical Lead, CTL, Clinical Scientist (CS), and Global Trial Manager (GTM) for the development of the study concept, study protocol ... Holds responsibility for site interactions in partnership with the Clinical Trial Leads (CTLs) for study -related medical... Clinical Trial Lead (CTL) and Global Trial Manager (GTM) to support executional delivery of studies… more
- Terumo Medical Corporation (Somerset, NJ)
- Sr. Manager , Clinical Advisors Date: Sep 25, 2024 Req ID: 3739 Location: Somerset, NJ, US, 08873 Company: Terumo Medical Corporation Department: Medical Affairs ... wherever we go next!** **_Advancing healthcare with heart_** **Job Summary** Senior Manager , Clinical Advisor is responsible for developing and implementing the… more
- Bausch + Lomb (Trenton, NJ)
- … investigations and post-market studies . + Communicates with vendors and clinical trial sites regarding study conduct, data monitoring, logistical management ... or collaborates on required tasks prior to commencement of clinical trials that include, but are not limited to:...of follow-up and close out study visits to ensure compliance with protocols and GCP… more
- Bristol Myers Squibb (Princeton, NJ)
- …plan for complex programs that have a large impact on the business. Ensures clinical studies are aligned with target label indications and are designed to ... and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Position...studies , with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication +… more
- Bristol Myers Squibb (Princeton, NJ)
- …lead, develop, motivate and achieve results through teams, and is the direct manager to Clinical Trial Physicians (CTPs) **Key Responsibilities** + Accountable ... studies , with the support of the CTPs and Clinical Scientists (CS) within the asset and/or indication +...Scientist for the design, execution, and analyses of each study led by the CTPs and CSs. Should work… more
- Merck (Trenton, NJ)
- …with company requirements and regulations are delivered and sustained. The Country Clinical Quality Manager (CCQM) has an important impact in achieving ... right company for your long-term goals. Our company's Global Clinical Trial Operations (GCTO) team is currently recruiting for...must have completed at least (2) years of collegiate study by June of 2025 **Preferred Experience and Skills:**… more
- WuXi AppTec (Plainsboro, NJ)
- …**Responsibilities** **Essential Job Functions:** + Responsible for all aspects of clinical monitoring and required reporting, including pre- study visits, site ... **Overview** The Clinical Research Associate III Senior Oncology performs and...of current developments in Phase I - III oncology studies relative to assigned projects. + Trains and manages… more
- University of Pennsylvania (Philadelphia, PA)
- …budgets, patient visits, transporting specimens, data entry, query resolution and working with study monitors). The Program Manager will work closely with major ... operations of clinical research proposals for their team. The Program Manager will work with Investigators and data informatics teams/programs to ensure the… more
- Takeda Pharmaceuticals (Trenton, NJ)
- …of budget setup including parameters for assigned studies . + Partner with Study Start up Managers, CROs, Clinical Operations teams, and TAU partners to ... **_A_** **_CCOUNTABILITIES:_** + Manage negotiations, finalization and administration of Master Clinical Trial Agreements. + Responsible for assigned study level… more
- Edwards Lifesciences (Trenton, NJ)
- …medical Sponsor assessment of adverse events and device deficiencies reported through clinical studies (eg assessment of seriousness, relationship to device and ... ** Manager , Medical Safety Officer - Transcatheter Heart Valve...regulatory submissions. + Provide input into safety sections of study protocols, regulatory submissions, and clinical /regulatory reports,… more
- Terumo Medical Corporation (Somerset, NJ)
- …propose new projects/business case or pursue product line extensions, labeling revisions, clinical studies , and any other activities to enhance the performance ... Sr. Product Manager Date: Sep 7, 2024 Req ID: 3692...product development initiatives, and accelerating market evaluation testing and clinical study activities. + Construct Marketing Specifications… more
- Bristol Myers Squibb (Princeton, NJ)
- …**Responsibilities:** + Oversee and manage the complete lifecycle of biospecimens collected for clinical studies with minimal supervision. + Core Clinical ... samples, loading documents to Shared Drive folders, etc.). + Independently reviews clinical study protocol providing comparison of vendor statement of work… more
