- Merck & Co. (Rahway, NJ)
- …of 6-14 Clinical Research Associates (CRAs) and to ensure excellent study and site performance with strict adherence to local regulations, company Standard ... Operating Procedure (SOPs) and International Conference on Harmonization Good Clinical Practice (ICH GCP.)As line manager , the role is critical to continuously… more
- Arthrex (Naples, FL)
- … clinical , biomaterials and biomechanical professionals. Arthrex is actively searching for an Associate Clinical Study Manager to join the Orthopedic ... eTMF design, CTMS design, and user testing for assigned studies Respond to site inquiries for study -related...with protocols, case report forms, and information packets for clinical studies Assist with recruiting and qualifying… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ... planning and execution of clinical studies ,...issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction ... and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is... Manager role is primarily a tactical study delivery role, reporting into an Associate … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ... planning and execution of clinical studies ,...issues with the reconciliation to the attention of the Study Manager and propose remediation plan.Distribute key… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...management systems and archiving systems. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Novo Nordisk Inc. (San Antonio, TX)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leveraging competencies, tools, and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... disabilities.SummaryThis position supports early phase oncology development and leads complex studies in study design, statistical analysis and interpretation of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …capacity management in accordance with budgetary requirements and emerging priorities to ensure studies are delivered as planned and critical study timelines are ... centered around rare diseases and immune disorders. Summary The CRA Oversight Associate Director plays an integral role in the strategic development, oversight, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as ... and represents function to standards team as an extended part of committee. Advise Study Data Manager on complex vendor management issues and provides guidance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Associate Director Global Oncology Value Access & Pricing will both develop and ... and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access… more
- Catalent (Philadelphia, PA)
- …located in the Philadelphia area is Catalent's global Center of Excellence for Clinical Supply Packaging. Catalent offers GMP secondary packaging and clinical ... a single product or multiple products as determined by study requirements. We offer manual patient kit assembly along...and high-speed automated carding to meet the needs of studies of all sizes. For temperature sensitive products and… more
- DivIHN Integration Inc (San Diego, CA)
- …and assistance to department Manager (s) and Director(s). candidate will support the Clinical Operations teams with ongoing conduct of studies . Needs to be ... regulations, relevant SOP's and internal tracking systems. To assist in tracking of clinical studies and site related purchase orders, invoice receipt, and… more
- George Washington University (Washington, DC)
- I. JOB OVERVIEW Job Description Summary: The Program Manager is primarily responsible for administering and managing international programs for students and faculty ... of SMHS, including international clinical and research electives for students and residents, scholarships, medical and surgical missions, the Global Health Track and… more
- Vera Therapeutics (Brisbane, CA)
- Title: Clinical Trial Manager Associate Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... for patients suffering from immunological diseases. Position Summary: The Clinical Trial Manager Associate will... study teams for assigned responsibilities of a study / studies . Responsibilities: * Manages assigned parts (vendor… more
- Merck (Columbus, OH)
- …of 6-14 Clinical Research Associates (CRAs) and to ensure excellent study and site performance with strict adherence to local regulations, company Standard ... Operating Procedure (SOPs) and International Conference on Harmonization Good Clinical Practice (ICH GCP.) As line manager ,...commitments in a timely manner in coordination with the study CRM. + Attend local Investigator Meetings if requested… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …for this role. The position can be based in Armonk, NY or Basking Ridge, NJ._ A Clinical Study Associate Manager (CSAM) role supports the Clinical ... sites may be required to assist with monitoring clinical studies . **A typical day as CSAM...like:** + Lead/oversee the planning and management of a clinical study in an assigned region(s) in… more
- Astrix Technology (New York, NY)
- Clinical Research Associate Clinical Project Manager /Scientist New York, NY, US Pay Rate Low: 71 | Pay Rate High: 84 + Added - 10/05/2024 Apply for Job ... company in the world - with complementary businesses in Surgical and Vision Care. ** Clinical Research Associate ** + Monitor and manage clinical trials, at… more
- Actalent (Basking Ridge, NJ)
- …Clinical Study Leader or Clinical Study Associate Manager . This person will support internally sourced studies and studies out-sourced to ... Specialist/In-house CRA provides technical and administrative support to the clinical study team(s) responsible for clinical... Clinical Research supporting Clinical Trial Managers/ Clinical Research Manager on studies … more
