- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilities. Summary This position supports proactive safety surveillance and risk management for assigned clinical studies in partnership with ... more focus areas (SME) Involved in audits/inspections for safety surveillance and risk management for assigned clinical studies, through inspection readiness… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Associate Clinical Research Manager (aCRM) - Oncology With support of other Clinical Research Manager 's (CRMs) ... Contact (POC) for assigned protocols and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned studies:… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionUnder the direction of the applicable management, the Lead Clinical Data Manager (LCDM) is responsible for executing end to end data management ... are not limited to: All responsibilities of a Senior Clinical Data Manager (SCDM) and a ...that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent… more
- Merck & Co. (Rahway, NJ)
- …quality standards and adverse event reporting requirements internally and externally.Our Clinical Research and Pharmacovigilance team push the boundaries of global ... healthcare through research and innovation. Through clinical trials and surveillance, we ensure the safety and...resolve issues, with minimal support from the Sr.COM or manager .Ability to make decisions independently with limited oversight from… more
- Tris Pharma (Monmouth Junction, NJ)
- …execution obligations Fosters a culture of quality-by-design in trial oversight and risk management across outsourced clinical trials, ensuring efficient issue ... vendors performing clinical study work May also function as a Clinical Trial Manager (CTM), as neededRequirementsSpecial knowledge or skills needed and/or… more
- Novo Nordisk Inc. (Atlanta, GA)
- … trials, in line with established targets and strategies Implements proactive risk identification and mitigation planning for assigned clinical trial sites, ... About the Department The Clinical , Medical and Regulatory (CMR) department at Novo...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Merck & Co. (Rahway, NJ)
- …case report form (CRF) data, lab data, other external data, biomarker data, and clinical outcomes assessments.2. Serves as project manager of all clinical ... Job DescriptionThe Trial Manager creates and ensures the successful execution of the clinical data management strategy for assigned trials within a specific… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... difference? The Position The CMR Business Planning & Strategy Manager will be responsible for facilitating the creation and...and resource strategies for a VP Function of the Clinical Development, Medical & Regulatory Affairs (CMR) Business Unit.… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary Position supports safety monitoring and risk management activities, provides insights on current clinical practice ... to aid the SMT's signal identification efforts.Safety Expert - Signal Evaluation: Assists manager in assessing new signals.Safety Expert - Risk Mitigation &… more
- Merck & Co. (North Wales, PA)
- Job DescriptionOverview:The Associate Director Publication (Pub) Manager is the central source of information regarding publication activities and is responsible for ... global publication strategies and tactical plans. The Associate Director Pub Manager oversees compliance with our company's publication policies and procedures and… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma. Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role Overview ... The QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...within a cell therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment.… more
- Alternate Solutions Health Network LLC (Columbus, OH)
- …and by following the order sets and goals created by the Case Manager . Interacting with patients' families while caring for your patients and experiencing the ... the attending physician and observe and monitor patient conditions and notify case manager of any changes in the patient's condition.Minimize Patient Risk :… more
- Catalent (San Diego, CA)
- …, Quality AssurancePosition Summary:Catalent Pharma in San Diego, CA is hiring a Senior Manager of Quality Assurance (QA) at our Clinical Supplies facility. As a ... Site Leadership Team, you will partner with the General Manager to create and sustain a site culture of...manufacturing and stability storage and testing as well as Clinical Supply Services. At Catalent San Diego, we recruit… more
- Merck & Co. (Ames, IA)
- …The position will require developing trial protocols, monitoring and summarizing clinical and marketing support trials specific to Ruminant animal health.- Position ... in its discretion that the nature of the role presents an increased risk of disease transmission.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Provide timely and accurate update on the timeline, status of the projects, risk and mitigation strategy to the manager and cross functional stakeholders. ... immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Manager /Sr. Manager , External Manufacture as part of the Technical Development… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... contracting agreements. In collaboration with the Associate Director, the Associate Manager will support CMR's partnership and alliance contract management strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the end-to-end delivery of External data in Daiichi Sankyo R&D collaborating with clinical and medical teams, clinical safety and pharmacovigilance, CROs and ... delivery of all 3rd party data from diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …System [QMS] QA, PV/MA Quality) and in close collaboration with CAPA Manager .), on GxP topics/issues impacting the respective clinical programs.Help to ... Business Units. Provide strategic and proactive QA Leadership for respective GPTs and Clinical Programs in close alignment with the Head of R&D QA. Within assigned… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …helping to ensure that the E&CDepartment takes a holistic view of risk management, considering broad organizational priorities as well as external insights. ... interacts, and provides direction to, information technology, Commercial Effectiveness, Clinical Operations and Marketing Effectiveness. Strong collaborations with senior… more
- Merck & Co. (North Wales, PA)
- …single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.Develops worldwide product regulatory ... regions simultaneously.Reviews and provides final approval Worldwide Marketing Applications, Clinical Study Reports, Protocols, Investigators' Brochures before release from… more
