- DivIHN Integration Inc (Columbus, OH)
- …regional contract CRAs, and organizes the files and budgets associated with several clinical studies . Provides medical support which may include: Adverse Event ... safety issues concerning foods or products and, by supporting clinical study teams with safety-related aspects and...data, medical and scientific data orally and in writing. Clinical Monitor or Research Coordinator Education: Associate … 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
- 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
- Merck & Co. (North Wales, PA)
- …with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the set up ... drives scientific planning, strategy and execution of Phase 1-4 clinical studies . Under the direction of the...you will collaborate with global, cross-functional team members including clinical directors and study managers to lead/support-… 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)
- …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)
- …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
- 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
- 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
- Dartmouth Health (Manchester, NH)
- …needs. * Plans adequate staffing and adjustments in alignment with patient volume and clinical needs. * Helps to manage the ASC, to ensure clinical competency ... staff, quality of patient/family centered care and professional development of clinical staff. * Identifies opportunities for best practices and continued… more
- Dignity Health (Phoenix, AZ)
- …academic conferences. This role reports jointly to the Senior Project Manager , Clinical Operations leader, and the study PI. Elevate your career while making ... for steering the regulatory affairs of a groundbreaking multi-center clinical study in translational ALS research. Join...(CIP), Certified IRB Manager (CIM) or Certified Clinical Research Associate (CCRA) preferred. Special Skills… more
- Lilly (IN)
- …in the study planning, execution, and close out activities of clinical studies . + Proactively identifies potential technical and operational issues/risks and ... and Analytics colleagues such as the CRF Standards Lead, Clinical Data Manager and other key stakeholders...Data Associate , Clinical Data Management Associate to deliver study database per business… more