- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… more
- Genmab (NJ)
- …integrity? At Genmab, we are seeking a passionate and experienced Senior Medical Writing Manager to help us tell the story of our science through compelling ... clinical and regulatory documents. You'll be at the heart...regulatory submissions (eg, NDA, BLA, MAA).Drive collaboration with cross-functional trial teams to manage timelines, facilitate meetings, and lead… more
- Genmab (NJ)
- …accountable for driving the strategy, quality, and integrity of external data across the clinical trial portfolio. This role serves as a Subject Matter Expert ... to interpret discrepancies and resolve data issues.Cross-functional CollaborationCollaborate with Trial Management, Clinical Operations, Medical, Biomarker Management,… more
- Genmab (NJ)
- …listings, and figures)(Preferred) Practical knowledge and experience using R to support clinical trial analyses.About YouYou are genuinely passionate about our ... we would love to have you join us!The Programming Manager supports the development of new therapies by ensuring...will support the Data Management, Statistics, Drug Safety, Medical, Clinical Pharmacology and Biomarker functions with the above by… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Eisai, Inc (NJ)
- …includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness ... difference. If this is your profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with RandD IT to implement and maintain Eisai's… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and laboratory data expertise to promote and implement best practices across the Clinical Trial lifecycle.- Applies GCP principles to ensure all laboratory data ... requirements to DM standards teams and program teams.- Advise Manager , Laboratory Data Management on complex textbook range and...CRO); oncology, immunology, or complex disease Strong knowledge of Clinical trial data systems and/or EDC lab… more
- Genmab (NJ)
- …of all aspects of clinical drug development, with particular emphasis on clinical trial design, trial execution, and strong knowledge about the ... allocation process of a program and/or study.Must understand the Clinical Trial matrixed process from research through...external environment may impact their area of responsibility. People manager : Lead a small/ local team to ensure oversight… more
- Eisai, Inc (Nutley, NJ)
- …clinical development in that he/she will be responsible for designing clinical trial , performing data analysis, supporting regulatory interactions, overseeing ... development in that he/she will be responsible for designing clinical trial , performing data analysis, supporting regulatory...within the clinical development. Works with the clinical , project management, and data manager teams… more
- Novo Nordisk Inc. (Providence, RI)
- …Sales Representative also assists their target physicians with their local clinical and educational initiatives by coordinating company resources (eg, counterparts, ... the Specialty Field Sales Representative reports to the District Business Manager of the specific sales territory. The Specialty Field Sales Representative… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Collaboration and partnership with other functions and stakeholders in supporting clinical trial monitoring and execution through RBQM activities. Accountable ... technical and career, of direct reports, and mentors or acts as functional manager of skip-level or ex-US staff. This position requires strong knowledge about RBQM,… 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
- Boehringer Ingelheim (Ridgefield, CT)
- …or can commute to our Ridgefield, CT office or who are willing to relocate. The Clinical Trial Manager (CTM) /Senior CTM is accountable for the operational ... if applicable, Patients (eg, lay summaries). **Requirements** **Education and Requirements** ** Clinical Trial Manager Education/Experience Requirements:** +… more
- ICON Clinical Research (Boston, MA)
- As a CLinical Trial Manager you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare ... data review and verification activities to ensure accuracy and consistency of clinical trial data. + Nurtures and maintains relationships within the Clinical … more
- Actalent (Austin, TX)
- The Senior Clinical Trial Manager will oversee the execution of clinical studies across multiple geographic regions, ensuring compliance with Good ... trial feasibility, site identification, and qualification activities. + Monitor clinical trial performance and quality metrics, addressing issues and risks… more
- Actalent (Parsippany Troy Hills, NJ)
- …materials. Additional Skills & Qualifications + 7+ years of experience as a GLOBAL Clinical Trial Manager with a pharmaceutical or biotech company. + ... Job Title: Senior Clinical Study Manager The Senior ...ensure compliance with quality measures and timelines. + Monitor clinical trial performance and quality metrics, escalating… more
- Boehringer Ingelheim (Ridgefield, CT)
- …means working from the Ridgefield, Connecticut site 2-3 times per week typically. The Clinical Trial Contract Manager is responsible for the preparation, ... executes a variety of agreements (eg, master services agreements, confidentiality agreements, Clinical trial agreements, etc.) + Reviews contract language and… more
- University of Utah (Salt Lake City, UT)
- …**Open Date** 05/19/2025 **Requisition Number** PRN41958B **Job Title** PS Manager , Clinical Research **Working Title** Clinical Trial & Post Award ... managing effective support and alignment with key resources for the entire clinical trial portfolio. The incumbent will act as a catalyst between the Institute… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Clinical Operations is responsible for the worldwide execution of all Phase I ... - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in… more
- Gilead Sciences, Inc. (Foster City, CA)
- …their aspirations. Join Gilead and help create possible, together. **Job Description** Clinical Operations is responsible for the worldwide execution of all Phase I ... - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in… more
