- 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
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Clinical and Pharmacovigilance teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new ... and Head of Clinical Quality Operations, the Clinical Quality Operations Manager (CQOM) is accountable...Quality Assurance (QA) and acting as the link between Clinical Development, study teams, global business functions… 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
- Novo Nordisk Inc. (Phoenix, AZ)
- …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
- Aequor (Thousand Oaks, CA)
- …regulatory guidelines impacting supply (ie GxP, SOX) High attention to detail Understanding of clinical study conduct Ability to operate in a team or matrixed ... remote schedule and be available at the committed times. Qualities/characteristics the hiring manager is looking for in candidates to work best with their team:… 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
- Actalent (Basking Ridge, NJ)
- …developed in house ! This company has great culture and is rapidly growing! Summary: The Clinical Study Associate Manager role supports the Clinical ... versus oversight of CROs deliverables will vary accordingly. The Clinical Study Associate Manager... sites may be required to assist with monitoring clinical studies . Qualifications: + 5+ years of… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …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
- Danaher Corporation (New York, NY)
- …experience as a Clinical Research Associate , Clinical Project Manager , Study Manager or other related professional role. + Fundamental knowledge ... and good understanding of GCPs, clinical trial design, study development and project management. + Experience in interpreting, preparing, writing, and presenting… more
- Taiho Oncology (Pleasanton, CA)
- Study Associate I, Clinical Operations...study team meetings and supports study manager with meeting minutes for assigned studies . + ... it most. This is an exciting opportunity to support clinical studies and experience multiple facets of...supportive, collaborative and global cross-functional environment. Position Summary: The Study Associate (SA) I is responsible for… 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. +… 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
- Stryker (Mahwah, NJ)
- …precision. **What you will do** As the ** Clinical Study Manager (CSM),** you will manage ongoing Investigator-Initiated Studies and/or Stryker Initiated ... by visiting stryker.com Stryker is seeking to hire a ** Clinical Study Manager ** to support...work experience required + Related clinical trial associate , clinical study associate… more
- CSL Behring (King Of Prussia, PA)
- …biotherapies used to treat serious and often rare conditions. Could you be our next Senior Clinical Lab Study Manager ? This position is located in our King ... have multiple direct reports. You will report to the Associate Director of Bioassay and Sample Management. You will...laboratory teams and will work with the program directors, clinical teams and R&D teams offering scientific and strategic… more
- Medtronic (North Haven, CT)
- **Careers that Change Lives** The ** Clinical Studies Support Coordinator IV** in the **Surgical Robotics Operating Unit** supports clinical studies by ... Life** . Provide project/program coordination and support to Global Clinical Study team . Maintains study...6 years of relevant experience **Nice to Have** + Associate 's or Bachelor's degree preferred + 7+ years' experience… more
- Fenway Health (Boston, MA)
- …the direction of The Fenway Institute's Associate Medical Director and the Clinical Research Operations Manager , the Study Coordinator will work with ... and trainings + Develops and implements recruitment plans for studies . + Meets regularly with study staff...sponsors, funders, collaborators and staff + Works with Research Associate and other study staff in general… more
- ICON Clinical Research (Raleigh, NC)
- …(preferably in Life Sciences) * Minimum of 1 years' experience or understanding of clinical study start up requirements and activities. * Experience of ... Collaboration, Partnership and Integrity. We want to be the Clinical Research Organisation that delivers excellence to our clients...an industry. **The Role:** As a member of the Study Start Up Team, you will play an integral… more
