- Regeneron Pharmaceuticals (Cambridge, MA)
- 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 ... and/or complex clinical trials from study design, through execution, to study close out. The Senior CSL is accountable for the study timelines, study budget, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …bring life-changing therapies to patients worldwide. **_Objective / Purpose:_** The Senior Manager, Clinical Partner Outsourcing (CPO) ensures seamless execution ... outsourcing models, including financial and commercial constructs + Sound understanding of GCP , ICH guidelines, and clinical trial regulations + Strong strategic… more
- ICON Clinical Research (Worcester, MA)
- …and maintain data management documentation and guidelines in accordance with Good Clinical Practices ( GCP ) and Good Documentation Practices (GDP). + Provide ... Developer you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. **What you will be… more
- Bausch + Lomb (Boston, MA)
- …global team members, other B&L departments (eg, R&D/Project Management, Clinical /Medical Affairs, Biometrics, Regulatory Affairs, Quality Assurance, ... GCP and B&L SOPs. + Responsible for the quality of all study-related documentation (eg, Trial Master File,...purposes. **POSITION REQUIREMENTS** **:** + Strong knowledge of Good Clinical Practices ( GCP ), clinical trials… more
- Takeda Pharmaceuticals (Boston, MA)
- …staffing model and vendor partnership strategy. They will ensure delivery of timely and quality coding deliverables for clinical trials and programs in order to ... Develop and maintain strong relationships with vendors who perform clinical trial coding, ensuring high quality deliverables,...GCP , regulatory and ICH guidelines as applicable to clinical data management and medical coding; clinical … more
- Takeda Pharmaceuticals (Boston, MA)
- …study management team members in order to deliver operational consistency and high quality support across clinical trial programs. + Provide guidance and ... the execution of studies in a matrix management structure to ensure compliance with quality standards (including ICH GCP , local regulations and Takeda SOPs). +… more
- ICON Clinical Research (Boston, MA)
- As a Senior CRA (ONC) you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Roles and ... specific trials. Trials may include both early and late phase clinical trials. + Develops meaningful site relationships through consistent collaborative… more
- Astellas Pharma (Cambridge, MA)
- …with other Medical Heads across Oncology and Biopharma/Cell&Gene and with senior leadership of Clinical Operations, Quantitative Sciences, Regulatory and ... and Early Development and Translational Sciences, to ensure optimal strategic and quality input and delivery in planning of clinical development strategies,… more
- Deloitte (Boston, MA)
- Senior Data Scientist, Specialist Senior - SFL Scientific Our Deloitte Strategy & Transactions team helps guide clients through their most critical moments and ... in building industry-specific, artificial intelligence (AI) technologies. We are hiring a Senior Data Scientist to collaborate directly with clients to design and… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and leadership to the Global Quality function with responsibilities for Global Clinical Quality (GCQ), CSV and GPV. In this role, the leader oversees ... **Data Integrity:** Ensure the accuracy, consistency, and reliability of clinical and PV data through robust Quality ...industry environment + Strong knowledge of current global Good Clinical Practice ( GCP ) for designing, recording and… more