- 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
- 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
- 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 , 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- We are seeking a ** Senior Manager , Clinical Sciences** to lead in the development, evaluation, planning and execution of clinical studies and ensures ... scientific integrity and interpretation of study data of a clinical development program. The Senior Manager...clinically relevant sections and review other scientific portions of clinical trial protocols and amendments + Assisting… 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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …operational planning activities. This includes regular updates on new information that could impact clinical trial execution as well as ad hoc requests to input ... + Proficient in the navigation of intelligence database(s) + Prior experience in Clinical Trial Operations + Basic knowledge in the monitoring and sourcing… more
- Bristol Myers Squibb (Madison, NJ)
- …work and in their personal lives. Read more: careers.bms.com/working-with-us . Senior Manager , Commercialization Competitive Intelligence (CI) plans and ... competitive intelligence and/or relevant pharmaceutical industry experience is preferred at Senior Manager level + Experience in hematology/oncology/cell therapy… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …internally sourced studies and/or CRO/Partnered studies. Collaborates and interacts with clinical trial managers, development program managers, medical monitors, ... The **Sr Manager , Clinical Drug Supply & Logistics**...orders according to supply plans or as requested by Clinical Trial Management team, to ensure timely… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …+ If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred + If you have a high attention to detail; ... The Sr. Manager , Regulatory Affairs will report to the Global...the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …advantage + Experience in delivering CMC/CP sections of marketing authorizations, clinical trial applications (CTA/IND) and post-approval submissions + ... to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings with country specific regulatory mentorship… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …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
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- The Senior Manager Development Operations & Portfolio Management (DO&PM) Vendor & Relationship Management (VRM) position is responsible to ensure that ... documentation maintenance, and SOP compliance checks. As a Sr Manager DO&PM Vendor and Relationship Management, a typical day...of 8 years of experience and success in a clinical trial /life sciences management role. Experience working… more
- Regeneron Pharmaceuticals (Basking Ridge, NJ)
- …across multiple therapeutic areas (ie, understanding of statistical concepts, techniques, and clinical trial principles) and ability to manage and lead ... related subject area + 10+ years of programming experience preferably in processing clinical trial data in the biotechnology, pharmaceutical or health related… 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… more