- Daiichi Sankyo, Inc. (Bernards, NJ)
- …transparent communication.Member of the Clinical Operational leadership team and global clinical operations committee enabling cross functional and regional ... to ensure the effective and efficient execution of operational aspects of clinical study planning, implementation, data delivery and reporting. Will represent… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for ... Organization (CRO) Medical Monitor (MM):Provides oversight to the CRO MM for clinical data review activitiesMay support addressing eligibility and medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …individual assuming this role may function as a key member of the Global Product Team in collaboration with Clinical Development, Regulatory, Project Management, ... the safety leadership and serving as the primary point of contact.Review and analyze data from clinical trials, post-marketing and other relevant sources for the… more
- Eisai, Inc (Nutley, NJ)
- …and internal process audits Facilitate Sponsor health authority inspections of global clinical facilities and study sites Continuously drive innovation ... an associated functional discipline (advanced degree preferred) with minimum 12 years in clinical research/ operations/ data management or related area. 5+ years… more
- Merck & Co. (Lower Gwynedd, PA)
- … data insight tools, and other applications required during non- clinical and clinical bioanalytical testing.-Benchmarks current approaches/techniques to the ... Adaptability, Algorithmic Design, Audits Compliance, Biochemical Tests, Biomedical Engineering, Clinical Testing, Communication, Computer Science, Data Visualization,… more
- Insmed Incorporated (San Diego, CA)
- Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform the lives of patients living with serious and rare diseases. Our most ... and Best Medium Workplaces™ lists.OverviewReporting to the Executive Director of Clinical Quality Assurance, the Director of Clinical Quality Assurance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Executive Director, Data Management (Head of Global Data Management) sets the ... BDM functions, sets the vision, direction, and strategy for Clinical Data Management globally and ensures execution...Data Management globally and ensures execution of the global data management strategy across regions and… more
- Merck & Co. (Rahway, NJ)
- …Skills:Business, Clinical Site Management, Clinical Testing, Communication, Data Management, Data Modeling, Global Sourcing, Mechatronics, Numerical ... Specific Required Skills and Experience:Significant expertise in SAS and clinical trial programming including data steps, procedures, SAS/MACRO,… more
- Merck & Co. (North Wales, PA)
- …results-oriented project management skills Preferred Experience and Skills: At least 5 years global or US medical affairs or clinical development experience with ... Job DescriptionThe Executive Director Pulmonary Hypertension, Value & Implementation (V&I), Global Medical and Scientific Affairs (GMSA) (referred to as EDMA) is… more
- Merck & Co. (Cincinnati, OH)
- …the Regional RMSD Team Leader - within US Medical Affairs, Global Clinical Development, Research and Development (R&D).--Primary Activities:Identify, establish ... (HH) strategies -Communicate external stakeholder opinions, insights and feedback on new data , clinical trends and the evolving vaccine landscape to Medical… more
- Insmed Incorporated (San Diego, CA)
- …development of custom tools, and data exchange solutions that enhance clinical trial efficiencySolid understanding of CDISC standards (CDASH, SDTM) and ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...the development and implementation of EDC systems to support clinical trials, ensuring data quality, compliance, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including all vendor managed activities with the goal of achieving the highest data quality standards , full adherence to patient's rights and well-being and ... or clinical development. requiredMust possess a solid understanding of global health authority regulatory requirements particularly in the areas of Medical… more
- Merck & Co. (North Wales, PA)
- …be programmed; an understanding of statistical terminology and conceptsFamiliarity with clinical data management conceptsExperience in CDISC and ADaM ... Primary Activities: Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Description:The Rahway based Senior Specialist, Global Development Quality Operations, is responsible for independent approval of documentation to ... support GMP clinical supply drug product manufacture, testing, release, and maintenance...or coordinate routine and specialized audits of batch documentation, data , information, procedures, equipment and systems, and/or facilities to… more
- Merck & Co. (North Wales, PA)
- …a program leader.Must possess familiarity with statistical analysis methods and clinical data management concepts; strong project management skills;Excellent ... deliverable quality and process compliance.Responsible for effective deliverable development utilizing global and TA standards that optimize analysis and… more
- Merck & Co. (North Wales, PA)
- …be programmed, an understanding of statistical terminology and concepts.Familiarity with clinical data management conceptsExperience in CDISC and ADaM ... Primary Activities :Effective analysis and report programming development and validation utilizing global and TA standards and following departmental SOPs and… more
- Merck & Co. (Upper Gwynedd, PA)
- …(V&I) Outcomes Research, position resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research.Under the ... resource utilization and costs, physician and patient satisfaction surveys, clinical and patient- reported outcomes assessments, systematic reviews and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …preferred- 4 or More Years experience in pharma at local, regional and/or Global level. preferred- Excellent knowledge of current clinical practice in Oncology ... to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the compound.- Responsible for scientific communications and publications; interpretation of clinical data ; ensuring consistency of clinical content and ... required- 4 or More Years experience in pharma at local, regional and/or Global level preferred- Excellent knowledge of current clinical practice in Oncology… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
