- Merck & Co. (North Wales, PA)
- …the Clinical Trial Team leadLeads and directs teams in key study planning , development, and execution elements (eg operational reviews, issue ... Job DescriptionThis position participates in the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders.Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the ... Study Associate Manager within Clinical Operations, in adherence to the protocol, Good ...milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).Responsibilities- Reconcile the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's (CRMs) ... and externally.The aCRM could be responsible for a particular study for a country or a cluster.Responsibilities include, but...and clinical research knowledge is required.Understanding of clinical trial planning , management and metrics is… more
- Eisai, Inc (Nutley, NJ)
- …led by Translational Science to evaluate biomarkers across programs, as well as the study statistician for clinical studies . As the statistical lead for ... managing CROs. The immediate need is to manage early clinical development studies primarily in support of...conduct to proactively address issues to ensure high quality study data (as needed). Clinical Study … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …on SDV plan. Performs literature review and creates reference list for study . Study Planning : Contributes to clinical trial planning including ... documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study Team and collaborates as team member with other functions,… more
- Merck & Co. (North Wales, PA)
- …position drives scientific planning , strategy and execution of Phase 1-4 clinical studies .-Under the direction of the Program Lead, you will collaborate ... with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the set up… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for DS Programs / Studies .Serve as the subject matter expert for Study Data Managers during the planning /start-up, conduct and close-out of external data ... of External data in Daiichi Sankyo R&D collaborating with Clinical and Medical teams, Functional Stakeholders, (QCP, Clinical...to support the collection of diverse external data types.Advises Study Data Manager on complex vendor management… more
- Tris Pharma (Monmouth Junction, NJ)
- … clinical study work May also function as a Clinical Trial Manager (CTM), as neededRequirementsSpecial knowledge or skills needed and/or licenses ... cross functional collaboration to develop program strategy and the implementation of clinical study processes and procedures ensuring timely execution of quality… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... Manages mutually beneficial relationships with external partners relevant to the planning and implementation of clinical trials improvement/innovation projects… more
- Novo Nordisk Inc. (Atlanta, GA)
- …North America Clinical Development (NACD) goals, including successful delivery of studies within the clinical trial portfolio. Contributes to local or ... Manages mutually beneficial relationships with external partners relevant to the planning and implementation of clinical trials and improvement/innovation… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and immune disorders. Summary Assist in planning and execution of clinical studies , under the supervision of the Study Manager role the Study ... and milestones to monitor and ensure compliance with Daiichi Sankyo Clinical Study Oversight Plan (CSOP).ResponsibilitiesReconcile the TMF document trackers… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …TLFs generated by statistical vendor, ensure deliverable quality for the pivotal studies , Integrated Summary of Efficacy (ISE)/Integrated Summary of Safety (ISS) for ... submissions. Responsibilities include: review Case Report Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and… more
- Merck & Co. (North Wales, PA)
- …least 2 years of experience in publication managementUnderstanding of the clinical development process andclinical study data for assigned ... Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Clinical Project Budget templates in support of early phase to late stage clinical studies . Accountable for the control and reporting of GEMRAD approved ... for a smooth consolidation process. Also responsible for managing various studies including late stage budget and forecasting, analysis, strategic planning… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Order process, bid defense meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when applicable. Serve as ... of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and...standards team as an extended part of committee. Advise Study Data Manager on complex vendor management… more
- Aequor (Thousand Oaks, CA)
- …of a driving range of Thousand Oaks. Some qualities that stand out to the hiring manager on resumes is: Looking for candidates who can be viewed as the top end of ... hands off leader, candidates who have familiarity with Pharma; Clinical Trials. Qualities an ideal candidate possess that will...ability to do the right thing (ethics). The hiring manager needs a candidate with the ability to be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials Review proposals for investigator-sponsored studies (ISS) and ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...Affairs point to identify investigators/sites and risks to trial planning and execution KOL and Association Engagement Assist Senior… more
- Eisai, Inc (Nutley, NJ)
- …training, advanced product training, improved selling skills, disease state knowledge, clinical and business acumen application of the Eisai Selling model and ... on training success metrics; demonstrating performance improvements and ROI impacts. Launch planning and execution : Partner with cross functional leaders to create… more
- Novo Nordisk Inc. (Chapel Hill, NC)
- …NNI and competitor products Demonstrates thorough knowledge of all promoted NNI approved clinical studies and the skill to engage customers (prescribers, support ... current co-promotion partners. Internally, the DCS reports to the District Business Manager of the specific sales territory. The DCS also interacts and collaborates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and support the PRA strategies and tactics of additional indications. With manager oversight, the individual will lead global pricing strategy development, access ... functions including but not limited to Commercial, Marketing, Medical, Clinical Development, Public & Government Affairs.Responsibilities- Lead the development of… more
