- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety related to managing assigned clinical trials, document management and management of clinical trial management systems and archiving systems. ... Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships...start up through closure, including but not limited to: Management of clinical trial documents, including but… more
- Aequor (NJ)
- …site level according to study (and IRT) requirements. Actively participating in Trial Supplies Management Functional team, Study Team, Country Medical Affairs ... 100 % remote Manager prefers local candidates (will consider non local...bachelor's degree Must Haves: Phase 1 to 4 clinical trial experience Managing end to end supply chain Job… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Provide input to process standards and tools to achieve excellence in trial operations and management .Monitor and ensure compliance and highest quality ... and reporting of all global oncology medical affairs operations clinical trial activities, ensuring adherence to timelines, budgets, project, and quality plans,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of the CRO scope of work in collaboration with Outsourcing Procurement Management .Lead trial feasibility and site identification activities in collaboration with ... and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key internal and external… more
- Novo Nordisk Inc. (San Antonio, TX)
- …Implements proactive risk identification and mitigation planning for assigned clinical trial sites, leveraging Risk Based Quality Management (RBQM) principles ... scientific integrity; regulatory and process compliance) for monitoring and site management activities. Takes ownership to deliver upon near-term North America… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical site performance through coordination and communication with CSSAs, CRAs and the Trial Manager (TM) for assigned trials, within the Therapy Area T ... and reporting of key metrics In collaboration with the Trial Manager , support, prepare for and follow-up...trials; with at least 4 years of direct site management and logistical clinical trial execution required… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management , is accountable for an end-to-end ... approaches to support the collection of diverse external data types.Advises Study Data Manager on complex vendor management issues and provides guidance or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … management skills in a complex, matrix environment including project management preferred- Experience in clinical trial design and improvement activities, ... areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or increasingly complex improvement/innovation projects ... approach, leveraging competencies, tools, and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to improve organizational efficiencies and cost controls.Communication and Relationship Management - Leads contract related communication with vendors. Respond to ... appropriate utilization and application of advanced negotiation skills, partnership management and strong interpersonal skills to support and advance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and other ... planning and execution of clinical studies, under the supervision of the Study Manager role the Study Associate Manager within Clinical Operations, in adherence… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to study deliverables; ... with commercial group regarding new indications for Life Cycle Management .Additional non-study related activities: Clinical Development involvement in due diligence… more
- Aequor (Piscataway, NJ)
- Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule: West Chester.PA (hybrid) Is this temp to perm? The manager intends to convert the ... FTE after a year Shift Type: Day M-F 9-5 Position Summary: The Manager /Sr. Manager , Medical Communications (S/MMC) supports publication strategy and plan… more
- Merck & Co. (North Wales, PA)
- …as part of a global, cross-functional team. You will apply project management , communication, and collaboration skills in support of our clinical trials.Job ... activities).May be responsible for tracking study timelines using project management tools.Shares technical expertise with team members.May interact with internal… more
- BioAgilytix (Durham, NC)
- The Regulatory Affairs Manager is responsible for coordinating the regulatory activities for projects including new products and life cycle management . This ... submissionsPrepare pre-market submission reports / technical files / clinical trial applications per the requirements of key regulatory agenciesCoordinates… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Reports to Associate Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders to develop comprehensive ... to close the knowledge gaps (for example: New TA knowledge, New Trial /Protocol etc.) Collaborate with Subject Matter Experts to ensure that training… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …function to standards team as an extended part of committee. Advise Study Data Manager on complex vendor management issues and provides guidance or feedback to ... and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as...complex disease required- 7+ years working knowledge of Clinical trial data systems and/or EDC lab management … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs and other ... also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.This position has a working knowledge of… more
- Merck & Co. (North Wales, PA)
- …This may include:Serving as the lead clinical scientist on a clinical trial team.Leading medical monitoring team in review and interpretation of clinical ... related study materials (eg, ICF documents/amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design supports data collection in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis dataset and TLFs ... deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds… more
