- Novo Nordisk Inc. (Plainsboro, NJ)
- …goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex cross-functional ... managing assigned clinical trials, document management and management of clinical trial management systems and archiving systems. Relationships Reports to a Manager… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and quality plans, ... and expectations. Ensure regular updates provided to Study Lead on trial metrics, data, and quality.Establish strong partnership with Functional and Regional… more
- Insmed Incorporated (Bridgewater, NJ)
- …of essential documents and maintenance of both paper and electronic Trial MasterFollows up with CROs, and/or functional area representatives on pending/outstanding ... TMF status updates and TMF metricsParticipates in the review of clinical trial agreements, CRO and vendor contractual documents, work orders, and other site/vendor… more
- Piper Companies (Salt Lake City, UT)
- Piper Companies is searching for a Clinical Trial Physician / Principal Investigator in Salt Lake City, Utah. The Principal Investigator will lead clinical ... development efforts for current and future clinical trial studies. This is a full time opportunity, with...a Monday - Friday schedule. Responsibilities of the Clinical Trial Physician include:. Monitoring patient safety throughout the full… more
- Tris Pharma (Monmouth Junction, NJ)
- …and supports the clinical operations function by outlining scope of clinical trial programs and aligning resource needs, timelines, cost of services, etc.; Provides ... to: progress, status updates, mitigation strategy/plans, escalation of issues for trial or program level deliverables to senior management, etc.); Develops,… more
- Novo Nordisk Inc. (Atlanta, GA)
- …goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex improvement/innovation projects ... and improvement/innovation projects for NACD and Novo Nordisk (eg, clinical trial site staff, clinical research vendors). Manages relationships with multiple… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on Medical & Science Team Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for ... and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …on demand planning, supply planning, and distribution requirements planning and Trial deliverables across NACD. This includes leading processes and technology ... improvements to link Clinical trial site needs, Finance and Supply forecasts that will...and CA warehouses operations for US and CA Clinical Trial sites. Accountable for overall performance management of Senior… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and other functional groups across NN. External relationships can include clinical trial sites and external vendors. Essential Functions Develop and ensure that the ... mitigate or resolve, for example across various topics, such as clinical trial management, deviation handling, and product quality Develop, execute, and maintain… more
- Merck & Co. (Rahway, NJ)
- …meetings with investigators and regulatory agencies in discussions about clinical trial issues and submission strategies.Ensures the statistical designs and analysis ... research activities for innovative statistical methods and applications in clinical trial development. Education and Minimum Requirement: PhD or equivalent degree in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …relating to the project portfolio anchored within the East Coast Hub, including trial planning, study / protocol design and development, execution within budget and ... development across projects Establish, implement, and proactively manage clinical trial processes, strategic outsourcing and performance indicators In collaboration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Oversees typically a single non-pivotal trial (small size, standard complexity in design and geographic scope). Prepares ... guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents… more
- Merck & Co. (Rahway, NJ)
- …is responsible for budget/finance aspects, for execution and oversight of clinical trial country submissions and approvals and to ensure Site Ready. Responsibilities ... and site budgets. Development, negotiation and completion of Clinical Trial Research Agreements (CTRA).Oversees and tracks clinical research-related payments.… more
- Merck & Co. (North Wales, PA)
- …field plus 5 years SAS programming experience in a clinical trial environment.MS in Computer Science, Statistics, Applied Mathematics, Life Sciences, Engineering ... field plus 3 years SAS programming experience in a clinical trial environment.Department Required Skills and Experience: Effective interpersonal skills and ability… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Internal relationships include working with Headquarters, NA CMR including Clinical Trial Management, Medical Affairs, Regulatory Affairs and other NNI skill areas. ... Clinical study management: Provide regional medical & scientific input on trial outlines, trial protocols and ICF Provide input on country and site feasibility,… more
- Merck & Co. (North Wales, PA)
- …years Statistical Analysis System (SAS) programming experience in a clinical trial environment. MS (preferred) in Computer Science, Statistics, Applied Mathematics, ... years Statistical Analysis System (SAS) programming experience in a clinical trial environment. Required Experience and Skills: Experience leading large and/or… more
- Merck & Co. (Rahway, NJ)
- …research activities for innovative statistical methods and applications in clinical trial development.Collaborates in publication of research results in areas of ... eg SAS and/or R.-Solid understanding of worldwide regulatory requirements and clinical trial expertise from phase II to V.-Excellent oral and written communication… more
- Merck & Co. (North Wales, PA)
- …as statistical representative in the cross-functional teams for the clinical trial planning, execution, and reporting.Develops individual protocols and data analysis ... research activities for innovative statistical methods and applications in clinical trial development. Minimum education required: PhD or equivalent degree in… more
- Merck & Co. (Rahway, NJ)
- …for the quality and timely execution and delivery of deliverables at the trial level. Primary activities include, but are not limited to: All responsibilities of ... adherence to a metrics control plan and quality assessment indicators at the trial level.Coordinate the database lock preparation and monitoring of checks, such as… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …accountable for inspection readiness of external data documentation filed/archived in Trial Master File (TMF) according to applicable Daiichi Sankyo and regulatory ... to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx...disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related applications is… more
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