- Parexel (Newton, MA)
- …of national or international airport due to travel obligations. Job Title: Senior Clinical Research Associate **Duties:** Parexel International LLC seeks a ... Senior Clinical Research Associate based in Newton, MA to monitor and oversee clinical trials at client sites. Evaluate quality and integrity of reported… more
- 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 (Boston, MA)
- …guidelines. + Enhances study procedures and processes to optimize efficiency and data quality throughout the clinical research lifecycle and performs data review ... with Clinical Development, Biostatistics and Data Managements, Regulatory, R&D, Quality and HEMAR and other internal partners to achieve project objectives. +… 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)
- …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
- Beth Israel Lahey Health (Burlington, MA)
- …research staff and Research Administration facilitating all aspects of assigned clinical trials. Interacts with study participants diagnosed with various medical ... and diagnoses. **Job Description:** 1) Possesses ongoing knowledge of FDA, OHRP and GCP regulations: + Ensures adherence to regulations. + Educates and mentors other… more
- Pfizer (Boston, MA)
- **POSITION SUMMARY** You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for ... program. + Responsible for scientific oversight, data integrity and quality of the clinical trial(s). + Authors...of the sponsor leading studies + Strong knowledge of clinical procedures, ICH guidelines, GCP and familiarity… 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