- Merck & Co. (North Wales, PA)
- …this role is to lead the coordination and execution of major change projects across Global Clinical Trial Operations. The role will also assist with Program ... Bachelor's degree with at least nine (9) years of pharmaceutical , clinical drug development, project management and/or...to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relevant Novo Nordisk experience may be substituted for degree, when appropriate Clinical trial experience within a pharmaceutical , biotechnology, CRO ... (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or...department (subset) of NACD and/or as part of a global team and as aligned to a business case,… more
- Insmed Incorporated (Bridgewater, NJ)
- …and collecting TMF status updates and TMF metricsParticipates in the review of clinical trial agreements, CRO and vendor contractual documents, work orders, and ... processing and timely payment execution of invoices related to clinical trial agreements and CRO/vendor Scopes of...a Clinical Operations Experience considered relevant includes clinical and/or basic research in a bio/ pharmaceutical … more
- Merck & Co. (North Wales, PA)
- … Clinical Safety StatisticsInteract with Safety Physicians, Safety Scientists, Clinical Trial Physicians , Regulatory, Early/Late Development Statistics, ... project management skills. --Good understanding of worldwide regulatory requirements and clinical trial expertise .Strong oral and written communication skills.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaboration and role consistency. Accountability for quality and performance related managing clinical trial sites (ie data quality, document handling, and ... those most recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical ...ICH-GCP principles and the application of those principles to trial design, planning & conduct of clinical … more
- Novo Nordisk Inc. (Nashville, TN)
- …50 mile radius of Nashville, TN. Qualifications A minimum of 4 years of clinical trial experience within a pharmaceutical , biotechnology, CRO, and/or ... (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or...department, (subset of) NACD and/or as part of a global team and as aligned to a business case,… more
- Merck & Co. (North Wales, PA)
- …a global basis. We are responsible for negotiating industry sponsored clinical trial agreements, confidentiality agreements, and other type of agreements ... of our company's diverse development portfolio comprising over 200 clinical trials in compliance with global and...minimum of 2 years of relevant experience in the pharmaceutical industry or an Associate's Degree with a minimum… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...Planning and Execution: Provides input on major milestones of trial , clinical trial plan and… 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 ... is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address...people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi… 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 ... impacting the respective clinical programs.Help to ensure in collaboration with Global Development Operations (GDO) ( Global Clinical Operations / … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Drives and leads the successful execution of all operational components of a large-scale global clinical program using strong clinical project and program ... preferred 4 or More Years with PharmD/PhD preferred Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department Our East Coast Global Development Hub brings together the best minds in life science innovation with facilities in Lexington, MA and Plainsboro, ... NJ. We support programs from early research through late-stage clinical development. We are building for the future, creating a distinct R&D community based on… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …as a Novo Nordisk representative in interactions with Health Authority Inspector(s) at clinical trial sites Support local/ global quality projects to improve ... monitoring experience required A minimum of 6 years of progressively responsible clinical trial experience within a pharmaceutical , biotechnology, CRO,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …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. ... all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting… 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
- Merck & Co. (Rahway, NJ)
- …Job Responsibilities: - Responsible for the operational planning, feasibility, and execution of a clinical trial .- May serve as the clinical trial ... degree + 5 years OR Master's + 3 years Pharmaceutical and/or clinical drug development experience OR...and skills: A plus with prior experience on managing global pediatric clinical trials (age 6 +),… more
- Tris Pharma (Monmouth Junction, NJ)
- …etc.) and minimum 7 years global Drug Safety/Pharmacovigilance clinical trial and post marketing experience in a pharmaceutical or biotechnology industry ... evaluation reports, etc.) Oversees reconciliation of safety data in pharmacovigilance and clinical trial databases Ensures audit and inspection readiness of Drug… more
- Merck & Co. (Rahway, NJ)
- …biomarker models, quantitative system pharmacology (QSP) and disease progression models, clinical trial design via outcome/enrollment modeling and simulation, ... Relationship ManagementPreferred Skills:Biological Sciences, Biomedical Engineering, Biopharmaceuticals, Chemical Engineering, Clinical Medicine, Clinical Trial Designs,… 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 ... or More Years with Bachelor of Science required- Experience considered relevant includes clinical or basic research in a Pharmaceutical company, a Medical… more
