- Parexel (Boston, MA)
- …the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely ... other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study...(CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. +… more
- Parexel (Boston, MA)
- …the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD). + Ensures timely ... other CRAs and the Local Study Team/ Local Study Associate Director (LSAD) to ensure that study...(CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as required. +… more
- CSL Behring (Waltham, MA)
- …a hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay. **Position Description Summary:** You will be part of a ... to developing therapies that make a meaningful difference worldwide. Could you be our next AD of Clinical Assay? The job is in our Waltham MA office. This is… more
- CSL Behring (Waltham, MA)
- …a hybrid position and is onsite three days a week. You will report to the Director of Clinical Assay. You will be part of a specialized non-laboratory based team ... to developing therapies that make a meaningful difference worldwide. Could you be our next AD of Clinical Assay? The job is in our Waltham MA office. This is… more
- GRAIL (Boston, MA)
- …+ **Experience** + Minimum of 10 years of experience in regulatory, development, clinical affairs, quality , or program management within the IVD, medical device, ... and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome… more
- Parexel (Boston, MA)
- **Job Purpose:** The Senior Clinical Research Associate (Sr. CRA) is responsible for the site management, site monitoring and close-out of assigned clinical ... + Support the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigators + Drive Quality Event (QE) remediation,… more
- Commonwealth Care Alliance (Boston, MA)
- 082310 InstED-Medical Expenses **Position Summary:** Reporting to the CMO/Medical Director and Associate Medical Director of instED, the Virtual Medical ... and relays any essential follow-up needs to the care team via the instED Clinical Resource Center (CRC) team. This is a per-diem position with a minimum commitment… more
- Takeda Pharmaceuticals (Boston, MA)
- …best of my knowledge. **Job Description** **About the role:** The Associate Director , Clinical & Quality Process Compliance is responsible for ensuring ... functional compliance teams for regulations impacting Clinical , Safety and Clinical Pharmacovigilance Medical Quality (CPMQ) processes and procedures and… more
- Takeda Pharmaceuticals (Boston, MA)
- …in the business units and affiliates. + Ensure that the Global Quality Audit functions consider clinical research and pharmacovigilance regulated activities ... (Global Audit, Compliance and Commercial Quality ) on fit-for-purpose Key Quality Indicators (KQIs) and metrics relevant to clinical research and… more
- Takeda Pharmaceuticals (Lexington, MA)
- …is true to the best of my knowledge. **Job Description** **About the Role:** The Associate Director of Device Clinical Development (DCD) in the Drug Product ... + Establish metrics to evaluate training effectiveness and implement continuous improvement ** Clinical Quality Assurance & Compliance:** + Implement quality … more
