- System One (Basking Ridge, NJ)
- Role: Clinical Study Associate I Type:...Assist in planning and execution of clinical studies , under the supervision of the Study Manager ... the Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...attention. Skills: Demonstrates knowledge of complex processes related to clinical studies , regulatory issues, CRO operations, and… more
- J&J Family of Companies (Trenton, NJ)
- …platform, including clinical studies , data science and new clinical and physiological applications. **Key Responsibilities:** + Study start-up and ... Sr Clinical Research Associate - 2406209639W **Description**...for consistency with case report form, and determine if clinical study subject documentation is within parameters… more
- Intra-Cellular Therapies, Inc (Bedminster, NJ)
- …Clinical Research Associate (CRA) is a key contributor to early phase/ clinical pharmacology studies . The CRA is responsible for the quality and compliance ... all we do, create and deliver. The in-house Clinical Research Associate / Senior ...and departmental meetings + May request cost estimates for clinical studies , manage purchase orders and invoices,… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- Clinical Study Associate Manager (CSAM)... sites may be required to assist with monitoring clinical studies . **A typical day might include the ... role supports the Clinical Study Lead (CSL) by taking responsibility for... trial delivery. This role applies to internally sourced studies and studies outsourced to Clinical… more
- Kelly Services (Basking Ridge, NJ)
- …**The Experts at Hiring Experts.** No C2C Full-time, perm, direct hire The Clinical Research Associate (CRA) is responsible for the implementation, monitoring, ... **Kelly(R) Science & Clinical ** is seeking a Senior Clinical ...Responsibilities:** + Serve as the primary liaison for assigned study sites, conveying project information, answering questions, and resolving… more
- WuXi AppTec (Plainsboro, NJ)
- **Overview** The Clinical Research Associate III Senior Oncology performs and coordinates aspects of field-based and office-based monitoring and data quality ... **Essential Job Functions:** + Responsible for all aspects of clinical monitoring and required reporting, including pre- study ...or supervisor, including but not limited to mentoring of Clinical Research Associate (CRA) I and II… more
- AbbVie (Branchburg, NJ)
- … review of study -specific documentation and training materials. + Writing of clinical study reports and specifically the clinical portions of regulatory ... @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn. Job Description The Associate Director, Clinical Development will have global or regional… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …(MDs) to provide scientific expertise necessary to design and deliver on clinical studies and programs. As an Associate Director a typical day may include ... studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Associate Director leads in a matrix… more
- Bristol Myers Squibb (Princeton, NJ)
- …key internal matrix relationships and key external stakeholders/clients + External: Clinical Study Sites, Institutional Review Boards/Ethics Committees, Vendors, ... + Internal: Global Trial Manager (GTM), Clinical Trial Managers (CTMs) Clinical Trial Monitors (CTMos), Study Start-up Specialists, Site Contract Leads,… more
- Hackensack Meridian Health (Edison, NJ)
- …activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues. + Collaborates with investigators to ... the principal investigator, clinical research coordinator, and clinical team, participates in the review of studies...prepare presentations or reports of clinical study procedures, results, and conclusions. +… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …and Modeling and Simulation plans, design and lead study teams to execute Clinical Pharmacology studies , conduct hands on population PK and PKPD analyses and ... + Serves as a specialist in PK-PD and Pop PK-PD concepts, phase 1-4 clinical studies , literature, and regulatory guidelines and can conduct/develop PK-PD and Pop… more
- Bristol Myers Squibb (Princeton, NJ)
- …Science function which provides scientific expertise necessary to design and deliver clinical studies and programs. **Position Summary / Objective** + ... Study committee (eg, DMC) activities + Drafting/review and validation of clinical study reports (CSRs) and clinical portions of Regulatory Documents (eg,… more
- Bristol Myers Squibb (Princeton, NJ)
- …and at governance meetings based on proficiency + **Provide input** to Phase 2/3 clinical study design and registrational strategy + **Accountable for the** ... Clinical Pharmacology Plan + **Lead** design of clinical pharmacology studies and manages data analysis,...in related field (MS, Ph.D. or PharmD) + For Associate Director level with Ph.D. approximately 5+ years experience… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Develops biomarker strategy in collaboration with Translational Medicine/Clin Pharm; May act as Clinical study leader (CSL) + Study Planning and Execution: ... Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project Teams. **Responsibilities** + Study Strategy:… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …of clinical studies and ensures scientific integrity and interpretation of study data of a clinical development program. The Senior Manager leads in a ... provide scientific expertise necessary to design and deliver on clinical studies and programs. As a Manager,...day may include the following: + Member of the Clinical Study Team and Global Clinical… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …**Job Summary:** The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more geographic regions, in adherence to ... and International Conference on Harmonization (ICH) guidelines. The Senior Clinical Study Manager will have routine interaction... Study Manager role is primarily a tactical study delivery role, reporting into an Associate … more
- J&J Family of Companies (Titusville, NJ)
- …Ability to work in a highly regulated environment. **Preferred:** * Knowledge of Clinical Supply Distribution, Clinical Study Execution, and GxP principles. ... part of the Johnson & Johnson Family of Companies, is recruiting for an Associate Director, Temperature Strategy & Execution within Clinical Supply Chain (CSC).… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary:** The Associate Director will lead the execution and lifecycle management of Global ... Medical Affairs' externally sponsored clinical research (ESR) initiatives, ensuring...guidelines. This role emphasizes the management of Investigator Initiated Studies (IIS) and Collaborative External Sponsored Research (CESR) projects.… more
- System One (Basking Ridge, NJ)
- …review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex ... Job Title: Associate Director, Biostatistics Client: Global Pharmaceutical Company Location:...rare diseases and immune disorders. This position leads complex studies in study design, statistical analysis and… more
- Bristol Myers Squibb (Princeton, NJ)
- …protocols. + Independently authors and/or reviews protocol, statistical analysis plan, clinical study reports, associated publications, and other study ... members. **Key Responsibilities** + Collaborates in design of innovative and efficient clinical trials, including the selection of study population/endpoints to… more