- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Functional Expertise:Reviews/approves clinical study related documents (eg, Protocols, Data Management Plan, Clinical Study Reports).Leads and ... diseases and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs… more
- Merck & Co. (Rahway, NJ)
- …research portfolio. The Global Clinical Operations (GDO) department in housed in Clinical Data Management and Standards (GDMS) within the GCTO ... activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead ...an understanding of the different skills and expertise of data management within a clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with Clinical ... (SME) Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection... Clinical Safety Scientist Lead and PSL or Clinical safety physician(s) to evaluate safety data … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …operations, oversight of initiatives and trouble-shooting issues. Liaison for CS Physician and Data Management for study related safety reporting. Will also act ... Operations. This position develops SAE Flow Plans and electronic data capture (EDC) Safety report outputs, reviews clinical... Data Capture (EDC) Responsibility: In conjunction with Data Management , establish the EDC strategy at… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in one or more clinical trial operations functions / sub-functions ( Data Management , Biostatistics, Clinical Science) preferred Travel:Ability to travel ... research areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is… more
- Merck & Co. (Rahway, NJ)
- …impact today.--Overview:-- -Merck Research Lab's (MRL) Pharmaceutical Sciences & Clinical Supplies (PSCS) organization is responsible for translating a therapeutic ... a functional drug product optimized for patients and for ensuring the availability of clinical supplies for patients. Within the PSCS team is the Global Clinical … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational activities ... from external sources.Ensure prompt and thorough review of requests for de-identified company clinical trial data .Ensure company clinical trial data … more
- Insmed Incorporated (San Diego, CA)
- …effective scientific and administrative operations. Operates, maintains, and repairs clinical laboratory equipment within scope of training including routine ... QC database. Set up and validate new assays as assigned by the manager .ResponsibilitiesManage and direct work responsibilities for team as well as prioritize tasks… more
- Novo Nordisk Inc. (WA)
- …a difference? The Position Drives the understanding and delivery of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific ... strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM)… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … trials. This position will work closely with other members of the Biostatistics and Data Management teams on various clinical projects and may function as ... areas centered around rare diseases and immune disorders.Summary The Manager / Senior Manager , Data ... data review listings and reports to support Data Management and clinical teams.Develop,… more
- Merck & Co. (Rahway, NJ)
- …Support development of Protocol and related study materials (eg, ICF documents/amendments, data management deliverables). - May interact with internal and ... of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of...close out of clinical trials within a program.- Clinical trials provide the required data which… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and stewardship communities across Daiichi Sankyo.- Remaining aware of and champion emerging data management skills and capabilities, including data quality, ... research areas centered around rare diseases and immune disorders.SummaryThis Data Governance Communications Manager will be a...master data management , metadata management , data change management and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … stewardship and governance processes, data cataloging data standards, data quality, and data management .- Develop and implement strategies for ... areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work...program, data stewardship program or similar intent data management program focused on setting standards,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global Regulatory ... Affairs (GRA) Process Excellence function, responsible for driving data governance, reporting, and analytics for RA. This will include working within and optimizing… more
- Merck & Co. (Rahway, NJ)
- …Provide visibility to the tools and processes used to maintain accurate project data in enterprise project management systems and databases. -Benefits of ... join us-and start making your impact today. -Overview: Global Project and Alliance Management (GPAM) sits in the research & development organization at Merck (Merck… more
- Aequor (New York, NY)
- …onboarding and oversight with business lines across GCS. Use technical operational and Clinical Development portfolio data to analyze and interpret past results, ... (SCBL) is responsible to advance and grow the Global Clinical Supply (GCS) business of delivering clinical ...a wide range of stakeholders. Excellent organizational and time management skills. Ability to aggregate detailed data … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managing our supply chain and sampling, supporting technological and data innovation, insights and analytics, delivering patient support solutions, maintaining ... of the Novo Nordisk Inc., (NNI) Procurement Methodology through Category Management and Strategic Sourcing activities. This position will ensure the acquisition… more
- Merck & Co. (Rahway, NJ)
- …accountable for the execution of the Merck clinical research portfolio. The Clinical Sciences & Study Management Department of the GCTO organization focuses ... close out of clinical trials within a program.- Clinical trials provide the required data which...and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Associate Manager will support CMR's partnership and alliance contract management strategy with a focus on: Partnering with stakeholders across CMR to plan, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR… more
- Catalent (St. Petersburg, FL)
- …and to the safety of every patient, consumer and Catalent employee. Compliance Manager is responsible for providing Leadership and Quality Assurance Management ... Document Control, Equipment/Facilities, Change Control, etc. The focus of each QA Manager may be dependent upon the needs of the business and structure… more
