- Novo Nordisk (Plainsboro, NJ)
- …internal and external partners, identify, qualify, manage, and maintain relations with clinical trial sites, including collaboration with PIs and patient ... Responsible for implementation of best practices and standards for clinical operations , including sharing lessons learned. Partner...preferred + A minimum of 12 years' progressively responsible clinical trial experience with at least 10… more
- Bristol Myers Squibb (Princeton, NJ)
- …in a global arena. + Expert in ICH/GCP principles as it relates to clinical trial execution and impact to the business supporting clinical trial ... personal lives. Read more: careers.bms.com/working-with-us . **Position:** Regional Head of Clinical Operations , United States and Canada **Position Summary**… more
- Sumitomo Pharma (Trenton, NJ)
- …Regulatory Affairs, Clinical Operations , and Medical Affairs to ensure the clinical program aligns with broader business goals. + Provide leadership and ... of the clinical programs, and liaises with Clinical (including Clinical Operations ), Biometrics,...to the end of the product's life cycle. + Clinical Trial Oversight: Develop and oversee … more
- Edwards Lifesciences (Trenton, NJ)
- …exam results for consistency with case report form, and determine if clinical trial /study subject documentation is within parameters of study hypothesis, ... as well as to monitor clinical trial /study safety, in keeping with protocols,...leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Committees, Clinical Operations (eg Contracts), and recommend and… more
- Bristol Myers Squibb (Princeton, NJ)
- …Summary / Objective** + Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical Trial ... team members + May support clinical development planning (collaboration with Clinical Development Lead/ Clinical Trial Physician for provision and… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …with the CRO and the study team. Oversee the site qualification process. + Monitor clinical trial performance and quality metrics and share with study team, ... are equally important. Outside interfaces may include other Daiichi-Sankyo business groups and subsidiaries in the US and abroad,...is required with a BSc required + Experience in clinical operations methods and processes in industry… more
- Bristol Myers Squibb (Princeton, NJ)
- …Summary / Objective** + Responsible for implementation, planning, and execution of assigned clinical trial activities. + Successfully leads, plans, and executes ... + Proficient knowledge of GCP/ICH, drug development process, study design, statistics, clinical operations . + Proficient knowledge and skills to support program… more
- Vitalief (New Brunswick, NJ)
- …of the research and clinical trials environment through optimizing existing business operations , and continually improving the success of our client's ... (SMO) focused on improving the value and contribution of clinical trial sites across the research and...+ 10 or more years of combined consulting and clinical research operations experience, successfully delivering innovative… more
- Vitalief (New Brunswick, NJ)
- …demands of the research and clinical trials environment, optimizing existing business operations by partnering with key client stakeholders to develop, ... partner focused on improving the value and contribution of clinical trial sites across the drug development...significantly contribute to our growth and recognition in the clinical research industry by fulfilling our clients' business… more
- Bristol Myers Squibb (Princeton, NJ)
- … development, the position is responsible for various aspects of ongoing clinical trial program-related activities within the relevant therapeutic area. These ... support of NDA/MAA filings. **Job Responsibilities:** + Acquires and utilizes knowledge of clinical trial design to develop or oversee development of specific… more
- Bristol Myers Squibb (Princeton, NJ)
- …projects + Efficiently plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner for assigned projects + ... their personal lives. Read more: careers.bms.com/working-with-us . The Senior Manager, Clinical Data Management (Data Management Lead) is a role considered essential… more
- Mallinckrodt Pharmaceuticals (Bridgewater, NJ)
- …phase 4 and registry studies, working with other internal stakeholders including clinical operations , statistics and regulatory. + Provides scientific and ... scientific and medical activities with other internal stakeholders (ie, commercial, clinical operations , statistics, regulatory, etc.) as they relate to… more
- J&J Family of Companies (Raritan, NJ)
- …in the development of the EGS / EDS + Develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials ... supervision + Plan for study budgets and collaborate with Clinical Operations to manage the development of...product development processes, team dynamics, related healthcare market environment, clinical trends, and global clinical trial… more
- Novo Nordisk (Plainsboro, NJ)
- …development, effective execution of CMR foundational and role-specific/technical training (eg clinical trial -related, GxP, Compliance, etc.) across the US and ... the strategy, development, effective execution of CMR role-specific/technical training (eg clinical trial -related, patient safety, therapeutic area leads, MSLs… more
- Bristol Myers Squibb (Princeton, NJ)
- …Requirements** + Expertise in GCP/ICH, drug development process, study design, statistics, clinical operations + Recognized internally and externally as a ... progress reports and risk assessment updates to Sr. Management + Reviews and approves clinical contributions to all trial documents / abstracts / publications +… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …TA Operations leadership + Identify and implement opportunities for innovation within clinical trial operations and identifies trends or competitors in ... one of more therapeutic areas in Clinical Trial Management (CTM). The Executive Director TA Operations...impose undue hardship on the operation of the Company's business . For roles in which the hired candidate will… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Master's Degree preferred **Experience:** + Minimum of 5 years of Global Clinical Trial experience in the device/pharmaceutical/CRO industry required. + ... This position reports to the Associate Director Data Management Operations . Business administration activities within the CDR...This position will also work with members of Data Operations , DM, and Biostatistics, Clinical Study teams,… more
- Sanofi Group (Bridgewater, NJ)
- …project strategy, its endorsement by governance and its execution in close collaboration with clinical operations . The CRD is expected to advance scientific and ... with the global project team and internal partners such as clinical operations , translational medicine, regulatory affairs, biostatistics, drug discovery,… more
- Bristol Myers Squibb (Princeton, NJ)
- …in late stage drug development and activities required for and related to clinical trial initiation, maintenance and completion + Strong verbal and written ... and be responsible for setting strategy for translational activities including clinical biomarker activities to support drug development programs. This individual… more
- Bristol Myers Squibb (Princeton, NJ)
- …Business Process Owners (eg Biostatistics, Regulatory, Clinical Development, Safety and Clinical Trial operations ). This position will be critical to ... **Position Summary** Support the design and deployment of the Business Process Management program to manage and optimize key...(six sigma training is a plus); within Drug Development ( Clinical Development, Trial Operations , Biostatistics,… more