- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and execution and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and ... veterans and people with disabilities. Summary Provide support for all aspects of Global Clinical Operations with a high degree of quality in the execution of all… more
- Novo Nordisk Inc. (Atlanta, GA)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... clinical trials and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... and timely execution and delivery of deliverables at the trial level. Primary activities include, but are not limited...are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a … more
- Merck & Co. (Rahway, NJ)
- …the person is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. ... to:Ownership of country and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).Oversees and tracks clinical … more
- Merck & Co. (North Wales, PA)
- …clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study ... including clinical directors and study managers to lead/support clinical trial scientific-activities.Job ResponsibilitiesResponsible for the clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … trial data. Review and approve resources for FMA Train Sales Teams on clinical trial data and Prescribing Information Train Market Access team on ... encore abstracts, reviews, and supplements) in collaboration with Publications Manager Independent Medical Education (IME) Assist in developing medical...clinical trial data and Prescribing Information Review and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... oncology, immunology, or complex disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related applications is a… more
- Merck & Co. (North Wales, PA)
- …Job Responsibilities Responsible for the operational planning, feasibility, execution and conduct of clinical trial (s).Serves as the Clinical Trial Team ... (study team, subsidiary country teams, vendors, committees, etc.) in support of clinical trial objectives.Liaises with partners, vendors, and vendor management… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within... and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov).Under… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Applies GCP principles to ensure all external data ... and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as...or complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... clinical studies, under the supervision of the Study Manager role the Study Associate Manager within... and coordinate with DS Regulatory Operations to post trial information on required public forums (eg.clinicaltrials.gov).-… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Quality is consistently and proactively represented at program level and along the clinical trial process in support of a proactive quality risk management ... System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …HEOR and RWE concepts and its impact on pricing & access preferred- Knowledge of clinical trial designs; sound understanding of clinical development & life ... regions/markets Ensure compliance with legal requirements- Collaborate and provides input to Clinical on trial design, endpoints, evidence generation plans, and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... have to lead a complex, global team in charge of a global clinical program designed to support registration and develop value-enhancing life-cycle strategy. The GTL… more
- Boehringer Ingelheim (Ridgefield, CT)
- …can commute to our Ridgefield, CT office or who are willing to relocate._ The Clinical Trial Manager (CTM) is accountable for the operational and scientific ... are raised to Evidence team for timely action or mitigation. **Requirements** ** Clinical Trial Manager Education/Experience Requirements:** + Bachelor's… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Sr. Clinical Trial Project Manager (Center for Cellular Immunotherapy) Job ... clinical research operations. In this role, the Sr Clinical Trial Project Manager will... trial processes, and the conduct of clinical studies. Reference Information : The salary range… more
- Vera Therapeutics (Brisbane, CA)
- Title: Clinical Trial Manager Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on developing ... in certain settings such as kidney transplant. For more information please visit: www.veratx.com. Our values are the cornerstone...for patients suffering from immunological diseases. Position Summary: The Clinical Trial Manager will report… more
- Edwards Lifesciences (Irvine, CA)
- …transcripts, exam results for consistency with case report form, and determine if clinical trial documentation is within parameters of study protocol, as well ... and be part of our inspiring journey._ As the ** Clinical Operations Manager ** for our THV Core...as to monitor clinical trial /study safety, in keeping with protocols,… more
- Vera Therapeutics (Brisbane, CA)
- Title: Clinical Trial Manager Associate Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused on ... improve medical treatment for patients suffering from immunological diseases. Position Summary: The Clinical Trial Manager Associate will report to the… more
- Abbott (Lake Forest, IL)
- …and organizational needs **Technical skills/Knowledge/Abilities** + Advanced knowledge of clinical trial practices and regulations + Advanced knowledge ... team; escalates monitoring-related study timeline and quality risks to Clinical Program Manager / Clinical Project Lead...of clinical trial , design, clinical trial databases,… more
