- Integra LifeSciences (Princeton, NJ)
- …and set new standards of care. **SUMMARY** The Senior Quality Compliance Manager will lead, coordinate and perform corporate audits of the Quality Management ... readiness through aforementioned formal corporate audits as well as informal high- risk CAPA reviews, mock inspection role-playing and SME / auditee coaching… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …support to the innovative medicines business, including new product launches, clinical data and business development related announcements. **Digital & Social ... + Deliver timely, accurate, and balanced messaging to mitigate risk and protect corporate reputation across media and digital...changing dynamics. + The ideal candidate is anExperienced Senior Manager in PHARMA, strong writer, has the ability to… more
- Parexel (Trenton, NJ)
- …HAVE AT LEAST ONE YEAR OF DIRECT CENTRAL MONITORING EXPERIENCE The Manager , Central Monitoring is accountable for centralized monitoring activities for global and/or ... complex trials, analytical data review of key risk and/or operational performance data and presenting as an...data and presenting as an integral member of the Clinical Study team for clinical development studies.… more
- Parexel (Trenton, NJ)
- …- Need for SE Region - FL** **ONCOLOGY preferred** **Job Purpose:** The Clinical Research Associate (CRA) has local responsibility for the delivery of the studies ... the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines… more
- Parexel (Trenton, NJ)
- …+ May undertake the responsibilities of an unblinded monitor where appropriate ** Clinical /Scientific and Site Monitoring Risk ** + Maintain thorough understanding ... **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for...(DSMM) + Partners with SCP and Country Study Operations Manager (SOM) + When required Partners with other Study… more
- Parexel (Trenton, NJ)
- The Senior Clinical Research Associate (SrCRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local ... the preparation, initiation, monitoring, and closure of assigned sites in clinical studies, in compliance with Client Procedural Documents, international guidelines… more
- Parexel (Trenton, NJ)
- **PXL FSP - Join an organization shaping smarter, faster clinical development** PXL FSP is seeking a detail-oriented and proactive **Feasibility Study Manager ** ... fast-paced, data-driven environment and enjoys collaborating cross-functionally to ensure clinical programs launch with the strongest foundation possible. **Key… more
- Memorial Sloan-Kettering Cancer Center (New York, NY)
- …in advancing precision oncology. CGS faculty are at the forefront of clinical cancer genetics, using next-generation sequencing, advanced risk modeling, and ... Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of… more
- BeOne Medicines (Pennington, NJ)
- …analysis, and risk management. + Experience with tech transfer to clinical /commercial manufacturing facilities. + Knowledge of study design such as DOE and ... through the lifecycle of a project which include gap and risk assessments, generating technical transfer plans, process descriptions and control strategies,… more
- BeOne Medicines (Pennington, NJ)
- …This includes support for all TechOps areas including Supply Chain, Manufacturing, Clinical and Quality. The ideal candidate should bring experience working in a ... ERP long term roadmap. + Work with SAP Project Manager , (external) Consulting Team and (internal) Core Business Team...Integration Points between SAP and other systems. + Perform risk assessments of enterprise apps and work closely with… more
- Parexel (Trenton, NJ)
- …leverage your medical expertise to ensure the safety of patients in clinical trials and post-marketing settings. In this pivotal role, you'll perform comprehensive ... + Communicating and discussing issues related to review process with Line Manager / Project Leader/Designee + Interacting with internal and external stakeholders for… more
- Parexel (Trenton, NJ)
- …requests for Parexel studies, as applicable and/or appropriate for the MD + Providing risk assessment of clinical trials for local sponsorship as needed with the ... the development and/or review of study documents, such as clinical protocols, Medical Monitoring Plans (MMP), integrated clinical...actions contributing to the success of the study/project and risk mitigation + Creating a sense of urgency on… more
- Cordis (Trenton, NJ)
- …together. **We are the people behind the people who keep saving lives.** The ** Clinical Closure Sales Specialist** is focused on the support of the Cordis closure ... business within a selected geography and works in partnership with the Territory Manager and Associate Territory Manager to achieve daily sales objectives… more
- Mount Sinai Health System (New York, NY)
- **Job Description** Senior Clinical Risk Manager The Senior Clinical Risk Manager serves as a resource to staff to enhance patient safety, ... to protect the assets of the facility. The Senior Risk Manager supports the Risk ...of the Associate Director/Senior Director. 13. Serves as a risk management resource to all clinical and… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The Clinical Risk Manager reports to the Director of Risk Management and Patient Safety and is responsible for reviewing, ... risk management activities the Mount Sinai Health System (MSHS)., The Clinical Risk Manager conducts investigations and prepares reports as required by… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The Clinical Program Manager , Clinical Command Center is a Registered Professional Nurse, Physician Assistant, or Nurse Practitioner, who ... functions of health-system throughput, transfer center, quality, and delivery of care. The Clinical Program Manager , Clinical Command Center participates in… more
- Oracle (Trenton, NJ)
- …a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, usability, and risk management processes. You'll ... Clinical Evaluation standards. Key Responsibilities . Conduct and contribute to clinical risk analyses (per ISO 14971). . Collaborate on Failure Mode and… more
- Oracle (Trenton, NJ)
- …a Clinical Product Manager (Medical Device Focus), you'll provide clinical insight into product design, usability, and risk management processes. You'll ... Clinical Evaluation standards. Key Responsibilities . Conduct and contribute to clinical risk analyses (per ISO 14971). . Collaborate on Failure Mode and… more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- The **Global Quality Audit Manager ** is responsible for planning, executing, and reporting on global audits to ensure **Good Clinical Practice (GCP) compliance** ... across Contract Research Organizations (CROs), clinical laboratories, and clinical investigator sites. This role plays a critical part in maintaining the… more
- Mount Sinai Health System (New York, NY)
- **Job Description** The ** Clinical Trial Manager ** provides leadership and oversight for the planning, conduct, and management of clinical trials within the ... Center for Interventional Cardiovascular Research & Clinical Trials. This role ensures high-quality, efficient study execution consistent with institutional, FDA,… more
