- Merck & Co. (Rahway, NJ)
- …operational/executional arms within the business.-- - - Working independently, the Protocol Clinical Supplies Project Manager ( Protocol CSPM) designs strategic ... deliverables and prepares , analyses , and/or develops mitigation strategies for review with clinical partners and senior leaders.- - Works directly in the SAP… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …checks, data quality listings, SAP, Data Mgmt plan, providing strategic direction to Clinical Operations on SDV plan. Performs literature review and creates ... disorders. Job Summary: Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Manager , Clinical Data Repository Administration is a member of the ... maintenance of standard hierarchy structures and user access controls for all clinical studies. This position may have direct reports and/or dedicated external… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Summary: This position is responsible for enabling the on-time delivery of clinical supplies across the DSI portfolio. This role is primarily responsible for ... streams with key service providers and working with internal departments to progress clinical supply projects. Every effort has been made to identify the essential… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …execution of master agreements on a timely basis. Management and oversight of Clinical Development contracting process, review and approval in accordance with ... to become an expert in complex outsourcing models supporting Clinical RD and PH.1 to PH. IV outsourced services...the outsourcing process and procedures. (not a formal people manager ). Develops detailed bid analysis for the RD functional… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and forecasting for commercial and IMP relevant activities and QA batch review and release process as necessary.Complaint and Recall Programs Establishment: Manages ... commercial and IMP as a result of distribution practices, manufacturing sites, clinical sites and testing laboratories and assures they are documented and resolved… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... and clinical study report (CSR): Leads statistical activities for complex...for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager , Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and ... interpretation of study data of a clinical development program. The Sr. Manager leads...Expanded Synopsis and may author clinically relevant sections and review other scientific portions of clinical trial… more
- Mount Sinai Health System (New York, NY)
- …in the NY/NJ region. MSHS, World Trade Center Health Program (WTCHP) seeks a Clinical Pharmacy Manager that reports to Senior Manager , Pharmacy Benefits ... under the direction of the WTCH medical leadership. The Clinical Pharmacy Manager will have direct patient...practitioners as required + Performing prescription audits such as review to improve generic medication use, prescribing patterns and… more
- Actalent (White Plains, NY)
- …comprehensive assessment, medication review , and post-hospital discharge evaluation. The Clinical Assessment Manager will follow all Department of Health ... to accurate and timely completion of UAS assessments. The Clinical Assessment Manager serves as a valuable...than 120 days, and care needs. + Evaluate and review previous assessments (of all types) to ensure documentation… more
- Molina Healthcare (New York, NY)
- **Job Description** Job Summary Creates and delivers clinical training programs for clinical staff across the enterprise to orient employees to Molina ... clinical methodology, along with policies, processes and systems. Ensures... Social Worker/Counseling (or related field) License Certified Case Manager (CCM), Utilization Management Certification (CPHM), Certified Professional in… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction with key ... the US and abroad, governmental, academic, community and industry organizations. The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Manager , Clinical Sciences, Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures scientific integrity ... and interpretation of study data of a clinical development program. The Senior Manager leads...trial protocols and amendments * Assists with and may authors/ review documents related to trials, such as medical monitoring… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The Clinical Program Manager , Clinical Command Center is a Registered Professional Nurse, Physician Assistant, or Nurse Practitioner, who ... functions of health-system throughput, transfer center, quality, and delivery of care. The Clinical Program Manager , Clinical Command Center participates in… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The **Project Manager II** will oversee the entire portfolio of Investigator-Initiated Clinical Trials (IICTs)/ Clinical Research Sponsor ... collaboration among multidisciplinary teams to meet project goals. The Project Manager II will work closely with investigators, research teams, regulatory bodies,… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Safety Communication:** + Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical ... a project manager for other activities involving assigned product(s) or clinical studies, as needed **Qualifications** Successful candidates will be able to meet… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Safety Communication:** + Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical ... project manager for other activities involving assigned product(s) or clinical studies, as needed. **Qualifications** Successful candidates will be able to meet… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Safety Communication** + Collaborates with Clinical Safety Physician(s) for assigned clinical studies to review and revise CSPs, ICFs, Clinical ... project manager for other activities involving assigned product(s) or clinical studies, as needed. **Qualifications** Successful candidates will be able to meet… more
- VNS Health (Manhattan, NY)
- …or care manager generated requests for medical services and renders clinical determinations in accordance with healthcare policies as well as applicable state ... review of all components related to requests for services which includes a clinical record review and interviews with members, clinical staff, medical… more
