- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable ... centered around rare diseases and immune disorders. Summary: The Senior Director, Head of RBQM (Risk Based Quality Monitoring)...of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Merck & Co. (Rahway, NJ)
- …decision-making skills, expertise in leading large teams in the development of novel clinical trial designs and analysis methods in oncology, experience in ... including regulatory submissionsDemonstrated history of development and execution of innovative clinical trial designs and exploration of novel analysis methods… more
- Bristol Myers Squibb (Princeton, NJ)
- …both at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Manager , Clinical Data Management is a leadership role ... plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner...perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of… more
- Bristol Myers Squibb (Princeton, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . ** Senior Manager , Clinical Data Standards, Bristol-Myers Squibb Company** ... ten (10) years of post-baccalaureate experience. Must have experience with/in: + Clinical Trial Data, + Pharmaceutical development process, + Health Authority… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager , Oncology, 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 Senior ...clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists… more
- Catalent Pharma Solutions (Somerset, NJ)
- ** Senior Manager , Human Resources Clinical...sizes to advance new medicines from early development to clinical trials and to the market. Catalent ... position, located** **out of Bridgewater, NJ (HQ) or Philadelphia, PA.** The ** Senior Manager , Human Resources Clinical & Specialty Services** will support… more
- Actalent (Pennington, NJ)
- …Senior Clinical Project ManagerJob Description We are seeking a dedicated Senior Clinical Project Manager responsible for overseeing the planning, ... Experience working in an FDA-regulated and/or EMA-regulated environment. + Knowledge of adaptive trial designs and decentralized clinical trials is an… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The ** Senior Clinical Study Lead** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large ... and/or complex clinical trials from study design, through execution,...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …in authoring clinical study process improvements and SOPs. + Meets all requirements for Senior Clinical Trial Manager ( Senior CTM) grade 28 ... the worldwide execution of all Phase I - IV clinical trials across all Gilead therapeutic areas....global registration and commercialization of Gilead's products. As a ** Clinical Program Manager ** , you will oversee… more
- Taiho Oncology (Princeton, NJ)
- …to transforming the landscape of cancer treatment and improving patients' lives. As a Senior Manager , Clinical Research Scientist, you will play a pivotal ... at the forefront of cancer research. Position Summary: The Senior Manager , Clinical Research Scientist...and review of study data, analysis and reporting of clinical trials . Performance Objectives: + Collaborates with… more
- Vitalief (New Brunswick, NJ)
- …is carried out as outlined. + Develops and distributes monthly financial reports to senior leadership of clinical trial revenue activity including active ... of Sites, Sponsors, and CROs across the research and clinical trials landscape. By blending deep subject...benefit patients. We are seeking a talented and enthusiastic Senior Clinical Research Financial Analyst to join… more
- Mount Sinai Health System (New York, NY)
- … Manager II** will oversee the entire portfolio of Investigator-Initiated Clinical Trials (IICTs)/ Clinical Research Sponsor Collaboration (CRSC) within ... objectives are met. **Regulatory Compliance and Quality Assurance:** + Ensure all trials adhere to Good Clinical Practice (GCP) guidelines, institutional… more
- Mount Sinai Health System (New York, NY)
- …informed consent under supervision of the Principal Investigator, Clinical Research Manager , or Senior Clinical Research Coordinator for studies ... **Job Description** Under minimal supervision, coordinates the clinical assessments of the study subjects; analyzes and assists in interpreting moderately complex … more
- Bristol Myers Squibb (Princeton, NJ)
- …in their personal lives. Read more: careers.bms.com/working-with-us . **Position Summary:** The Senior Manager , Product Analyst, Clinical Data Management, ... (CDE) that primarily delivers technology strategy and solutions for clinical trial execution, data management and data...perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of… more
- Sanofi Group (Morristown, NJ)
- …Assurance and/or in Clinical Trials such as Monitoring or Clinical Trial Management with good performance + Extensive working knowledge of international ... **Job Title:** Clinical Project Quality Manager **Location:** Morristown,...from a quality perspective Understanding and experience with end-to-end clinical trial processes and functions including experience… more
- ConvaTec (Bridgewater, NJ)
- …reimbursement, proactively address policy risks, and integrate reimbursement requirements into clinical trial designs. This role requires close collaboration ... to anticipate reimbursement challenges and develop contingency plans. + Partner with clinical teams to design trials that capture payer relevant endpoints… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager provides timely support to the team on all programming matters according to the project strategies within a therapeutic area. As a part of a ... timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product...with 9+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical… more
- Bristol Myers Squibb (Princeton, NJ)
- …across a matrix. + Experience with drug development, commercialization, and healthcare, clinical trial management a plus. The starting compensation for this ... Cell Therapy Organization. This role reports directly to the Senior Director of Strategy and Operations, serving as a...perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager Statistical Programming for Medical Affairs provides timely support to the Medical Affairs project team on all programming matters according ... to regulatory approval, product launch, and annual reports. The Senior Manager Statistical Programming for Medical Affairs...timely and quality support for analysis and reporting of clinical trial data + Provide input into… more
