- 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
- Tris Pharma (Monmouth Junction, NJ)
- …vendors performing clinical study work May also function as a Clinical Trial Manager (CTM), as neededRequirementsSpecial knowledge or skills needed ... supports the clinical operations function by outlining scope of clinical trial programs and aligning resource needs, timelines, cost of services, etc.;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... to managing assigned clinical trials, document management and management of clinical trial management systems and archiving systems. Relationships Reports to… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific ... data, lab data, other external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager ...requirements for quality data collection and validation at the trial level.Reads and interprets the clinical protocol… 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. (Rahway, NJ)
- …of Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned ... Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology...and clinical research knowledge is required.Understanding of clinical trial planning, management and metrics is… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …literature review and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to ... immune disorders. Summary Drafts development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical… more
- George Washington University (Washington, DC)
- … research legal transactions including Confidentiality Agreements, Non-Disclosure Agreements, Clinical Trial Agreements, federally funded grants, contracts and ... Independently reviews, negotiates and drafts Confidentiality Agreements, Non-Disclosure Agreements, Clinical Trial Agreements, federally funded grants, contracts… 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
- 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 ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… more
- Aequor (Piscataway, NJ)
- …The S/MMC is expected to: Possess ability to understand and interpret clinical trial data, the literature and associated therapeutic conditions Coordinates ... Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule:...Ability to establish and leverage relationships with external experts, clinical trial investigators, journal editors, and congress… more
- Merck & Co. (Ames, IA)
- …FDA, CFIA and USDA regulatory policies.- The position will require developing trial protocols, monitoring and summarizing clinical and marketing support trials ... for all of our Company's Animal Health Division products. Perform field trial evaluation of newly license products to offer technical support information for… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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
- 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
- Russell Tobin & Associates (San Diego, CA)
- …compliance risks, measure performance metrics, and suggest areas for improvement for clinical trial related processes and procedures Lead or support ... we looking for in our R&D Quality Risk Management Manager ? The Scientific Team at Russell Tobin & Associates...Health Authority regulations Experience with drug development process - clinical protocol development, global trial management and… more
- ICONMA (Redlands, CA)
- . Global biosimilar development operational execution through oversight of cross functional trial activities in partnership with CRO. . Ensuring implementation of ... trial (s) in partnership with CRO in accordance with applicable...with applicable SOPs and ICH/GCP guidelines. . Execution of clinical studies with high-quality, on time, and within budget.… 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 ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in… more
- Option Care Health (Tallahassee, FL)
- …infusion services for a broad range of specialized therapies, as well as clinical trial services and special programs for pharmaceutical manufacturers. Joining ... always. Naven Health is a nationwide home infusion nursing network and clinical platform focused on delivering specialized, truly exceptional infusion care. With… more
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