- Merck & Co. (Rahway, NJ)
- … data , biomarker data , and clinical outcomes assessments.2. Serves as project manager of all clinical data management activities for trials as ... Job DescriptionThe Trial Manager creates and ensures the...clinical data management perspective.Provides clinical data management input into trial … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety related to managing assigned clinical trials, document management and management of clinical trial management systems and archiving systems. ... with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR...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)
- …monitoring plans.Accountable for accuracy and timeliness of information in all data management activities, databases and tracking systems.Company Sponsored ... activities and expectations. Ensure regular updates provided to Study Lead on trial metrics, data , and quality.Establish strong partnership with Functional and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …an equal opportunity employer including veterans and people with disabilities. Summary The Manager External Data Management , is accountable for an end-to-end ... collection of diverse external data types.Advises Study Data Manager on complex vendor management...disease therapeutic area is a must.Working knowledge of Clinical trial data systems and/or EDC and related… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …diseases and immune disorders. Summary Position manages end-to-end delivery of data management services for assigned projects/studies, collaborating with CROs ... This position also partners with internal and external stakeholders to optimize Data Management technology, processes, and standards.This position has a working… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …represents function to standards team as an extended part of committee. Advise Study Data Manager on complex vendor management issues and provides guidance ... meetings, and selection of vendors. Provide support to Study Data Manager with all invoice approvals if/when...7+ years working knowledge of Clinical trial data systems and/or EDC lab management tools… 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 ... guidelines, and relevant regulatory requirements Ensure accuracy, validity and completeness of data collected at clinical trial sites in accordance with the… 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)
- …in one or more key functions (eg, clinical research, clinical operations, data management , biostatistics, project management ) required- Collaboration, ... Management to respond to process metrics and trending data to identify gaps, and design/implement process improvements.-monitor and evaluate risks/issues… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Medicine and Clinical Pharmacology (TMCP), providing strategic direction to Biostatistics and Data Operations (BDO) for EDC, edit checks, data quality listings, ... and creates reference list for study.Study Planning: Contributes to clinical trial planning including identification of potential risks to study deliverables;… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... delivery of quality clinical research (patient safety, rights & wellbeing; data reliability; scientific integrity; regulatory & process compliance. Takes ownership… 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
- Aequor (Piscataway, NJ)
- …S/MMC is expected to: Possess ability to understand and interpret clinical trial data , the literature and associated therapeutic conditions Coordinates ... Job Title: Manager /Sr. Manager Medical Communications Hybrid schedule:...publications and scientific congress strategy and plans Possess project management skills to ensure execution of publication plans is… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved. The ... Reports to Associate Director or above within CMR Training & Knowledge Management . Collaborates with global and CMR leaders and stakeholders to develop comprehensive… more
- Merck & Co. (North Wales, PA)
- …data collection in alignment with the protocol in collaboration with Data Management /Programming.Collaborating cross-functionally to monitor clinical data ... prioritization skillsStrong analytical skills with the ability to interpret clinical trial data and synthesize conclusionsInteract with key stakeholders across… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor project timelines and resource planning, work in tandem with Biostatistics and Data Management members to ensure best vendor performance, monitor analysis ... Form (CRF) annotation and Study Date Tabulation Model (SDTM) dataset, identify data inconsistencies and support data review, review analysis dataset… more
- Merck & Co. (North Wales, PA)
- …prioritization skills.Advanced analytical skills with the ability to interpret clinical trial data and synthesize conclusions.Interact with key stakeholders ... members including clinical directors and study managers to lead/support-clinical trial scientific activities.Job Responsibilities Responsible for the clinical/scientific execution… more
- Axelon Services Corporation (Atlanta, GA)
- …site level according to study (and IRT) requirements. - Actively participating in Trial Supplies Management Functional team, Study Team, Country Medical Affairs ... Remote This position is responsible for the supply planning and inventory management of clinical supplies required to support global clinical research and… more
- Merck & Co. (North Wales, PA)
- …prioritization skillsStrong analytical skills with the ability to interpret clinical trial data and synthesize conclusionsInteract with key stakeholders across ... to produce safe, effective, innovative medicine.The Clinical Sciences & Study Management (CSSM) department is building the world's best Research and Development… more
