- 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
- 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 ... rare diseases and immune disorders. 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. (San Antonio, TX)
- … 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex ... of clinical trials improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, IRBs, clinical research vendors). Manages… 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 ... team members including clinical directors and study managers to lead/support- clinical trial scientific activities.Job Responsibilities Responsible for the … more
- Merck & Co. (North Wales, PA)
- …for the scientific aspects of the implementation and conduct of a clinical trial (eg, investigator meeting presentations, safety and medical monitoring)May ... serve as the CSSM scientific representative on the Clinical Trial Team (CTT)May work closely with...Team (CTT)May work closely with the Medical Writer on clinical /scientific and regulatory documents and the Study Manager… more
- Merck & Co. (Rahway, NJ)
- …reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking ... and ensures continuity of site relationships through all phases of the trial .Performs clinical study site management/monitoring activities in compliance with… 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. (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… 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)
- …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
- Insmed Incorporated (Bridgewater, NJ)
- …Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop ... efficiency and effectiveness, including Medical Expert mapping and profiling tools, manager coaching tool, etc. Identify innovative solutions to solve business… more
- FISI - FUJIFILM Irvine Scientific (Santa Ana, CA)
- …medical device and/or pharmaceutical industry.Master's degree or Ph.D. preferred.Familiarity with clinical trial design, conduct, and oversightExperience in EU ... Overview We are hiring a Clinical Affairs Program Manager . The ...work and make independent decisions, understand complex scientific and clinical data information , and be able to… 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
- 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
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …are submitted to sponsor in a timely manner, eg, 1572, Confidentiality Agreement, clinical trial agreements, IRB approval letter, Financial Disclosures, etc., as ... the Role:Job SummaryResponsible for the coordinating, implementing, and evaluating of clinical research trials. This includes all phases of research: Study… more
- Jazz Pharmaceuticals (Philadelphia, PA)
- …each assigned TA. Maintain accurate and updated training content by incorporating new trial data and disease state information , etc. for assigned TA.Collaborate ... the globe, serving patients in nearly 75 countries. For more information , please visit www.jazzpharmaceuticals.com and follow @JazzPharma on Twitter. Brief… more
