- Gilead Sciences, Inc. (Parsippany, NJ)
- …protocols, informed consents, case report forms, monitoring plans, investigator brochures and clinical study reports + Must be able to understand, interpret ... Coordinates review of data listings and preparation of interim/final clinical study reports + Assists in determining...regulations), ICH Guidelines, and GCP governing the conduct of clinical studies + Working knowledge and experience… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …+ Proven ability to successfully start-up, manage and close-out clinical studies , including authoring clinical study and regulatory documentation and ... SOPs. + Meets all requirements for Senior Clinical Trial Manager (Senior CTM) grade 28... studies . + Proven ability to effectively author clinical study and regulatory documentation. + Ability… more
- IQVIA (Bridgewater, NJ)
- …Clinical Lead is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies to meet contractual ... Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' lives… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures integrity and interpretation of study data of a ... necessary to design and deliver on clinical studies and programs. As a Senior Manager ...in collaborative activities with other departments; Member of the Clinical Study Team and Global Clinical… more
- Merck (Rahway, NJ)
- …and external stakeholders ( study sites, vendors, committees, etc.) in support of clinical study objectives. You will be part of a diverse, cross-functional ... end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager (LCDM); issuing queries… more
- Pfizer (New York, NY)
- …of all phases of clinical trials and ability to assess and determine study requirement from protocol review + Strong Project and Risk Management * CRO and vendor ... in the discovery sciences, ensuring drug safety and efficacy or supporting clinical trials, you will apply cutting edge design and process development capabilities… more
- Merck (Rahway, NJ)
- …Development + Forecast grant spend as well as provide financial support related to assigned clinical studies + Be the primary point of Finance contact for a wide ... stakeholders including the Global Project Manager , Alliance Manager , Global Trial Manager , Clinical ...and Collaborations Team for all project issues related to study budget, site and vendor related payments, asset valuation… more
- Weill Cornell Medical College (New York, NY)
- …of study coordination and study conduct for multisite investigator-initiated studies with a focus on large, pragmatic clinical trials. This key role ... Title: Clinical Research Project Manager Location: Upper...study coordination & conduct activities for multisite investigator-initiated studies in accordance w/ relevant regulations, Standard Operating Procedures… more
- Kelly Services (New York, NY)
- ** Clinical Research Study Start Up Manager ** **Position: Clinical Research Start-Up Manager - Hybrid** **Job description** : The Clinical ... Research Start-Up Manager is an experience clinical trial research professional with research-specific knowledge and skills,...clinical trials for the Research System . The Clinical Trial Start-Up Manager will train 5… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …complex assignments that enable multiple functions and teams to achieve their clinical study objectives within targeted timelines and allocated resource levels. ... their aspirations. Join Gilead and help create possible, together. **Job Description** Clinical Operations Oncology is responsible for the worldwide execution of all… more
- Regeneron Pharmaceuticals (Armonk, NY)
- …internal and external studies + Oversees and provides input to the study drug and clinical supplies forecasting, drug accountability and drug reconciliation ... The **Senior Clinical Study Lead** (CSL) is expected...implements the operational strategic direction and guidance for respective clinical studies + Demonstrates expert knowledge and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …immune disorders. **Summary** This position supports the strategy for driving global Clinical Study Start-Up activities for PV Safety Operations. This position ... and electronic data capture (EDC) Safety report outputs, reviews clinical study protocols and the Clinical... protocols to ensure consistency in safety requirements across studies related to a similar compound. Develops and maintains… more
- International Rescue Committee (New York, NY)
- Requisition ID: req45075 Job Title: Clinical Program Manager , Home Study and Post-Release Services Sector: Social Work Employment Category: Fixed Term ... HQ USA Work Arrangement:Hybrid Job Description SCOPE OF WORK: The IRC's Home Study and Post-Release Services (HSPRS) for unaccompanied children in the US is growing… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. **Summary** Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP). **Responsibilities** -… more
- The Mount Sinai Health System (New York, NY)
- The Clinical Trials Manager coordinates and manages multiple clinical trials projects and protocols, including those from pharmaceutical companies. This ... provides administrative oversight regarding staff roles and instructions for each study . **Strength Through Diversity** The Mount Sinai Health System believes that… more
- Boehringer Ingelheim (New Brunswick, NJ)
- …the procurement and sourcing strategy for the local categories with exposure to Clinical Studies and/or Non-Interventional Studies . This role will also ... an early stage. + Provide feedback to (Senior) Category Manager as needed. + Manage local Business Partners actively...digital therapies preferred + Familiarity with and exposure to Clinical studies and/or Non-Interventional Studies … more
- Danaher Corporation (New York, NY)
- …5+ years' 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… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …metrics, and provide this feedback through regularly scheduled 1:1 meetings + Collaborate with Clinical Study Manager on SA deliverables + Participates in ... who assist in planning and in the execution of clinical studies in adherence to the protocol,...Conference on Harmonization (ICH) guidelines. The Manager , Study Associates will ensure the SAs provide clinical… more
- Merck (Rahway, NJ)
- …progressive on-the-job training and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . **Your Fellowship ... of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of...for a single study or across multiple studies (eg, operational deliverables, clinical & ancillary… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …assigned clinical studies to review and revise CSPs, ICFs, Clinical Study Reports (CSRs), and review Statistical Analysis Plans (SAPs) and statistical ... as a project manager for other activities involving assigned product(s) or clinical studies , as needed Qualifications: Successful candidates will be able to… more