- 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
- 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
- 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
- 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)
- …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
- 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
- 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
- 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
- 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
- Merck (Rahway, NJ)
- …execution of clinical protocol(s). This may include: + Serving as the lead clinical scientist on a clinical trial team. + Leading medical monitoring ... study materials (eg, ICF documents/amendments); Partners with the Study Manager on study deliverables. + Ensuring CRF design supports...+ Strong analytical skills with the ability to interpret clinical trial data and synthesize conclusions +… more
- Merck (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 will partner with...& networking opportunities within and beyond Clinical Trial Operations . Exposure to Senior level… more
- Merck (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
- Pfizer (New York, NY)
- …develop resolutions to meet productivity, quality and client satisfactions goals. As a Senior Manager , your advanced knowledge of the principles and concepts in ... research, knowledge of Good Clinical Practices + Familiarity with clinical trial execution, working with contract research organizations, budget management,… 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
- Bristol Myers Squibb (Summit, NJ)
- …external questions regarding drug products. **Position Summary / Objective** The Senior Manager , GRS-CMC is responsible for content development, compilation, ... maintenance, and review of the Quality Module for regulatory submissions regarding: Clinical trial applications; New marketing applications; HA responses &… more
- Publicis Groupe (New York, NY)
- …you join a tight-knit community of award-winning creative directors and clinical trial designers, accomplished data-scientists and media specialists, behavioral ... stage of your personal and professional life. **Job Description** The Senior Program Manager leads the production of multi-channel projects of large size or… more