- Option Care Health (Bannockburn, IL)
- …and retaining a diverse workforce. Job Description Summary:Under the direction of the Sr. Manager , Clinical Risk Management, the Quality and Risk ... (listed in order of importance and/or time spent)Collaborates and communicates with Sr. Manager , Clinical Risk Management and Director, Quality & Risk … more
- 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and cultures. Additionally, this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience ... skills in continuous improvement, project management, change management, and risk management. ResponsibilitiesLeadership, Direction, and Strategy:Establishes Data Management strategy… more
- Merck & Co. (Rahway, NJ)
- …reporting requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking ... sites in a country.Under the oversight of the CRA manager or CRD, the person ensures compliance of study...allocated sites. Actively develops and expands the territory for clinical research, finding and developing new sites. Participates in… more
- Novo Nordisk Inc. (WA)
- … 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …line with established targets and including communication of updates Ensures proactive risk identification and mitigation planning for assigned clinical trial ... 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
- Merck & Co. (Rahway, NJ)
- Job Description Job Description: We are looking for a manager to lead and manage the validation and testing activities for our platform products. This role will need ... validation reports in alignment with GCP and 21 CFR Part 11 requirements. Risk -based validation approach: Knowledge and application of risk -based validation… 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
- 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. ... the treatment of multiple myeloma. Legend Biotech is seeking a Senior Manager /Associate Director, External Manufacture as part of the Global Manufacturing Supply… 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
- Novo Nordisk Inc. (Fort Worth, TX)
- …Internally, the Diabetes Educator reports to the Health Systems Diabetes Educator Manager (HSDEM). The Diabetes Educator primarily aligns and liaises with the Health ... System Account Manager (HSAM) and/or other internal key health system account...Functions Work with health systems accounts to identify "at risk " patient populations and utilize diabetes education following the… 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
