- 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
- Aetion (New York, NY)
- …administrative claims, electronic health records, and disease registries. Experience in the clinical trials space may meet this requirement Expertise in ... well as R programming and managing teams. As a Senior Director in the Research+Analytics team, you will hold...the Research+Analytics team, you will hold an active people manager role. As a successful candidate, you will manage… more
- Bristol-Myers Squibb Company (Summit, NJ)
- …and unique perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of passion, innovation, urgency, ... making process. Provides weekend coverage for manufacturing operations and is senior leadership support for any technical or manufacturing issues during weekend… more
- Bristol Myers Squibb (Madison, 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
- 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
- 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
- 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
- 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
- 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
- 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
- Bristol Myers Squibb (Summit, NJ)
- …products for both global clinical trials and commercial supply. The Senior Manager will play a vital role in the leadership, organization, and ... and unique perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of passion, innovation, urgency,… more
- Regeneron Pharmaceuticals (Sleepy Hollow, NY)
- The Senior Manager position within the Regulatory Affairs department requires the ability to apply clinical development knowledge in concert with experienced ... minimal guidance from the Regulatory Affairs, Advertising and Promotion Director. The Senior Manager Regulatory Affairs, Advertising and Promotion will oversee… more
- Bristol Myers Squibb (Summit, NJ)
- …and unique perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of passion, innovation, urgency, ... better place than here at BMS with our Cell Therapy team. The Senior Project Manager , Cell Therapy Business Process Management ( Senior Project Manager )… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …study team to ensure timely and quality support for analysis and reporting of clinical trials up to regulatory approval, product launch and annual reports. If ... SUMMARY: A Sr. Manager provides timely support to the project team...clinical task force. Meets statistical adhoc requests of senior management. SCOPE: N/A JOB RESPONSIBILITIES: * Independently coordinate… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- The Senior Manager of Global Patient Safety (GPS) will play a key scientific role in safety strategies for molecules in clinical development and ... and ICH guidelines, initiatives and regulations governing pharmacovigilance activities for both clinical trial and post-marketing environments + Ability to work… more
- Bristol Myers Squibb (Summit, NJ)
- …there's no better place than here at BMS with our Cell Therapy team. The senior manager is responsible to manage and provide oversight of a team. Primary ... author, review and approve technical and procedural documents. The senior manager provides leadership and guidance to...perspectives in a supportive culture, promoting global participation in clinical trials , while our shared values of… more
