- 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
- Eisai, Inc (NJ)
- …includes overseeing the daily global eTMF system related activities relating to clinical study Trial Master Files (TMF), ensuring regulatory inspection-readiness ... profile, we want to hear from you. The Sr. Manager is to lead collaboration efforts with RandD IT...regulations. The Eisai eTMF system has global users, including contract research organizations (CROs) which requires individual and appropriate… 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 ... similar environment (eg, CRO); oncology, immunology, or complex disease Strong knowledge of Clinical trial data systems and/or EDC lab management. required- 4+… 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
- 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 ... this position has direct interaction with research laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members.… more
- Boehringer Ingelheim (Ridgefield, CT)
- …which means working from the Ridgefield, Connecticut site 2-3 times per week typically. The Clinical Trial Contract Manager is responsible for the ... (eg, master services agreements, confidentiality agreements, Clinical trial agreements, etc.) + Reviews contract language...Clinical trial agreements, etc.) + Reviews contract language and prepares responses to negotiate contract… more
- Texas A&M University System (College Station, TX)
- Job Title Clinical Trial Support - Contract Administrator Agency Texas A&M University Department Research Compliance & Biosafety Programs Proposed Minimum ... (CCRC), Certified Clinical Research Associate (CCRA) Certified Clinical Trials Manager (CTM) . + Knowledge...the development of outreach programs related to human subjects research. Clinical Trial Support Services- Drafts, reviews, and… more
