- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Clinical Trial Information Disclosure Manager leads company operational ... and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …(FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine ... US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role...and the study team. Oversee the site qualification process.Monitor clinical trial performance and quality metrics and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and suggest innovative approaches to improve compliances and processes.- Some knowledge of clinical trial methodologies. Travel Ability to travel up to 10% ... review), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Executes statistical activities for low to… more
- Merck & Co. (Rahway, NJ)
- …executing end to end Data Management activities with the support and oversight of a Senior Clinical Data Manager (SCDM)/Lead Clinical Data Manager ... operational project assignments under the direction of an Operations Manager (OM). - Your Fellowship Project - - You...Fellowship - Mentoring & networking opportunities within and beyond Clinical Trial Operations Exposure to Senior… more
- Merck & Co. (Rahway, NJ)
- …Job Responsibilities: - Responsible for the operational planning, feasibility, and execution of a clinical trial .- May serve as the clinical trial ... This position leads the operational planning and execution of one or more clinical trials or significant aspects thereof. In this position, you will have the… more
- Merck & Co. (Rahway, NJ)
- …understanding of the systems and tools critical to the oversight and conduct of a clinical trial . Participate in team meetings to develop an understanding of the ... and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your...and expertise of the cross functional members of a clinical trial team. -Benefits of Fellowship Mentoring… more
- Merck & Co. (Rahway, NJ)
- …internal and external stakeholders (eg, study team, vendors, committees) in support of clinical trial objectives. You will be part of a diverse, cross-functional ... and operational project assignments under the direction of Lead Clinical Scientist and Lead Study Manager . Your...tools critical to the oversight and conduct of a clinical trial . Participate in team meetings to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …all external information of the program, including publications, regulatory documents, clinical trial registers, data release, etc. Accountable for protecting ... diseases and immune disorders. Summary The Global Team Leader, is a senior , cross-functional leader in Daiichi Sankyo's Global R&D organization. At Daiichi Sankyo,… more
- Insmed Incorporated (Bridgewater, NJ)
- …Planning, Coaching Framework, Field Impact Assessment, MSL functional onboarding, Clinical Trial Support Framework, etcOperational Excellence - Develop ... efficiency and effectiveness, including Medical Expert mapping and profiling tools, manager coaching tool, etc. Identify innovative solutions to solve business… more
- IQVIA (Bridgewater, NJ)
- Job Overview Senior Clinical Leads are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients' ... by bringing new drugs to the market faster. The Senior Clinical Lead is a member of...Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …authoring clinical study and regulatory documentation and SOPs. + Meets all requirements for Senior Clinical Trial Manager ( Senior CTM) grade 28 ... Gilead and help create possible, together. **Job Description** **POSITION OVERVIEW:** Clinical Operations is responsible for the worldwide execution of all Phase… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. **Summary** The Clinical Trial Information Disclosure Manager leads company operational ... and the WHO, IFPMA, and EFPIA-PhRMA principles. A member of the Global Clinical Trial Disclosure Platform and Operations Committee. Facilitates the company's… more
- Pfizer (New York, NY)
- …+ Document Management functions + Coordinate TMF Lock process & activities across clinical trial portfolio + Identify and resolve operational issues and ... Knowledge of quality requirements across a range of different countries + Clinical Trial Execution + Clinical Documentation + Vendor Management and Oversight… more
- Bristol Myers Squibb (Madison, NJ)
- … trials from study start to database Lock . **Position Summary / Objective** The Senior Manager , Clinical Data Management is a leadership role considered ... plans, coordinates, and delivers complete, high quality and reliable clinical trial data in a timely manner...and written communication skill s + Communicate effectively with senior management and cross-functional teams + K nowledge of… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager Clinical Scientist Hematology leads in the development, evaluation, planning and execution of clinical studies and ensures integrity ... on clinical studies and programs. As a Senior Manager in Hematology Clinical ...clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager , Hematology, Clinical Scientist leads in the development, evaluation, planning and execution of clinical studies and ensures integrity ... on clinical studies and programs. As a Senior Manager in Hematology Clinical ...clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assists… more
- Vitalief (New Brunswick, NJ)
- …is carried out as outlined. + Develops and distributes monthly financial reports to senior leadership of clinical trial revenue activity including active ... is responsible for preparing, maintaining, and negotiating budgets related to clinical trial activities. + Performs prospective reimbursement analysis according… more
- Bristol Myers Squibb (Madison, NJ)
- …at work and in their personal lives. Read more: careers.bms.com/working-with-us . The Senior Clinical Scientist reports through the Clinical Science function ... + Responsible for implementation, planning, and execution of assigned clinical trial activities. Serves as Clinical... narratives + Provision of information required by Protocol Manager for development of trial budget, CRO… more
- AbbVie (Florham Park, NJ)
- …concepts. + In-depth knowledge of CDASH and SDTM Standards In-depth understanding of clinical trial processes + Demonstrated ability to influence others without ... bringing people, process, and technology together to generate business value from clinical trials data. Our operational model is exemplified through execution and… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The ** Senior Clinical Study Lead** (CSL) is expected to operate with high-degree of independence and is accountable for the global execution of assigned large ... study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study...maintenance of study systems including but not limited to Clinical Trial Management System (CTMS), Trial… more
