- Merck & Co. (Rahway, NJ)
- …of accomplishments. Experience in Country Operations preferred. Deep knowledge and understanding of Clinical Trial processes, GCP and other clinical research ... Job DescriptionIt is critical that, for all company-sponsored clinical trials, patient safety, high quality data and...those objectives. -Under the guidance of the Regional Director, Clinical Quality Management (RCQM), the CCQM oversees all CQM… more
- Merck & Co. (Rahway, NJ)
- …and posters/oral presentations that report results from our company's General Medicine clinical trial program, as well as select early-stage development projects ... Skills Strong writing skills and competence in biomedical research General Medicine clinical trial publications experience Understanding of clinical research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Research Equity (CRE) strategy integrating diversity and health equity systematically in clinical trial planning and execution. This role will create an equity ... sites, and caregivers With Director, serve as NACD SME on clinical trial diversity for local and global forums, initiatives, and communications Identify… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …NOTE: This Project Lead Role is an Individual Contributor and sits at the Manager Grade level. This position is responsible for enabling the on-time delivery of ... clinical supplies across the DSI portfolio. This role as...to CSO Supply Planning as requested.Responsible for updating relevant Trial Master Files (TMF) with CSO-related documentsSupports the CSO… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and external data expertise to promote and implement best practices across the Clinical Trial lifecycle. Provide oversight and execution of the CDx development ... centered around rare diseases and immune disorders. Summary The Manager External Data Management, is accountable for an end-to-end...disease therapeutic area is a must. Working knowledge of Clinical trial data systems and/or EDC and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …deliverables, maintain all required study programming documentation required for Trial Master File (TMF)- Maintain institutional knowledge across oncology compounds ... training and ensure implementation of ADaM and TLFs standard in clinical trials analysis- Provide programming support to prepare regulatory requested analyses… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … Director and Clinical Operations lead Support investigator meetings Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations ... Medical Guidance Train Field Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources for FMA Train Sales… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and suggest innovative approaches to improve compliances and processes.Some knowledge of clinical trial methodologies. Travel:Ability to travel up to 10% Daiichi ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and leads technical teams in preparation of submission documents to include clinical trial applications/amendments (eg, IND, IMPD, IB) and marketing ... laboratory members, the Contract Manufacturing Organization (CMO), Labeling members and Clinical members. This position works with non-standard problems of some… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal relationships may include MA management, MA project management, Medical Communications, Clinical Trial Management, Clinical Development and Outcomes ... interests on cross-functional teams including, Field Medical Affairs, Medical Operations, Clinical Trial Management, HEOR, Market Access, Marketing and other… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …may include Medical Affairs, Regulatory Affairs, Marketing, Learning & Development, Clinical Trial Management, and Clinical Development. Essential ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...and will also have a reporting relationship with a manager /preceptor in the respective functional areas during their rotations.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW:** Clinical Operations is responsible for the worldwide execution of all Phase ... I - IV clinical trials across all Gilead therapeutic areas. Clinical Operations plays a key role in ensuring all Gilead clinical trials are performed in… more
- Lilly (Branchburg, NJ)
- …Organization to enable innovative supply chain solutions and speed the delivery of clinical trial materials for patients. This is accomplished by planning and ... Requirements Planning (MRP) system (SAP) and communications with key business partners.The Clinical Trial Supply Management Associate (CTSMA) is responsible for… more
- Actalent (Parsippany Troy Hills, NJ)
- … clinical study team in accordance with standards. + Act as the project manager of the clinical study team to liaise and coordinate with internal stakeholders ... Job Title: Clinical Study ManagerJob Description The incumbent will be...audit activities. + Provide oversight of the transmittal of trial and site-level documents to the Document Control Center… more
- IQVIA (Bridgewater, NJ)
- The Associate Clinical Project Manager /Local Trial Manager is a member of the core project team responsible for project delivery of clinical studies ... the Project Lead for partnering in overall project management, Clinical Lead for site management, the Project Management Analyst...coordination, tracking and financial analysis, and the Site Activation Manager as an expert in start-up. This is an… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …etc. + Oversees set-up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial Master File (TMF) etc. + ... Ensures compliance with the clinical trial registry requirements + Identifies outsourcing needs of the study and leads and oversees engagement, contracting and… more
- Bristol Myers Squibb (Summit, NJ)
- …clinical studies and programs. This position involves leading and executing clinical trial activities, collaborating with cross-functional teams, and liaising ... Will be responsible for design and execution of assigned clinical trial activities and work closely with...co-lead study team meetings in partnership with GDO protocol manager and collaborate with cross-functional study team members **Position… more
- Mount Sinai Health System (New York, NY)
- … Trials Manager , you will coordinate and manage multiple clinical trial projects and protocols, including federally funded studies, investigator-initiated ... + Strong management and leadership skills **Responsibilities** + Manages and coordinates clinical trial and related research studies conducted by the principal… more
- Abbott (New York, NY)
- …initiatives. The Clinical Lead Specialist is to support Abbott TAVI US clinical trial and commercial case coverage, trial enrollment and sales ... in collaboration with the Regional Sales Directors and the Clinical Lead Manager (CLM). This position will...proper patient selection. + Serving as primary resource for clinical trial and lead/coach/commercial case support, demonstrating… more
- Mitsubishi Chemical Group (Jersey City, NJ)
- …and batch traceability. + Oversees CPOs to ensure compliance with GMP, GCP, applicable Clinical Trial Regulations and agreed Work Orders and Clinical Supply ... and creating hope for all facing illness. The Senior Manager , Clinical Supplies will manage the complete...years of experience in labeling, packaging and distribution of clinical trial materials. + Experience in managing… more
