- Parexel (Boston, MA)
- …delivering effective CAPA management solutions. + Experience with risk management tools and processes within the clinical quality framework. + Superior ... Purpose:** The Clinical Quality Operations Manager (CQOM), in collaboration with the Clinical Quality Operations Lead (CQOL) and Head of Clinical Quality… more
- Sumitomo Pharma (Boston, MA)
- …is a member of the Clinical Operations leadership team, responsible for Risk -Based Quality Management , Operational Data & Analytics, Records Management ... studies is conducted in alignment with regulatory requirements, leverages risk -based quality management methods and SMPA best...+ Lead and provide oversight of the Clinical Records Management (Trial Master File) team… more
- Takeda Pharmaceuticals (Lexington, MA)
- …combination product development programs. This pivotal role involves orchestrating device clinical and risk management strategies, establishing comprehensive ... outcomes that exceed quality benchmarks and regulatory standards. **Core Responsibilities:** **Device Clinical Strategy & Risk Management :** + Develop Device… more
- ConvaTec (Lexington, MA)
- …role to the success of Convatec's clinical trials. The Sr. Manager, Clinical Operations oversees the management of the day-to-day operations of clinical ... input into budget forecasting activities. + Support the selection, oversight, and management of Clinical Research Organizations (CROs) and other vendors for… more
- Dana-Farber Cancer Institute (Newton, MA)
- …of Supportive Oncology. This role is an exciting opportunity to provide ambulatory clinical oncology social work services and lead the Institute-wide Universal ... + Ability to provide guidance/ consultation to the team around complex patient management , including ethical issues; may require clinical consultation to plan… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …management . + Establish effective mechanisms to monitor compliance, issue, and risk management of development programs and strategic suppliers, ensuring ... organization, establishing a strategic leadership and oversight of the Takeda's clinical development programs and ensuring risk -based quality interventions and… more
- Baystate Health (Springfield, MA)
- …errors. ** Risk Management and Mitigation** + Partners with ** clinical risk management ** , to lead safety event investigation, risk ... 5+ years in a leadership role related to patient safety or risk management . + Strong knowledge of hospital operations, clinical workflows, and safety science… more
- Lilly (Boston, MA)
- … clinical studies, managing CROs and vendors to ensure high-quality execution. + Lead internal clinical trial team meetings, tracking key study metrics (eg, ... of quality assurance activities and coordinate remediation of audit findings. + Lead vendor selection, contract/budget negotiation, and management (including RFP… more
- Takeda Pharmaceuticals (Boston, MA)
- …adequately assessed and reported within the timelines. + Lead the Clinical Program Quality, Deviation Management and Serious Breach review board meetings. ... **How will you contribute:** + Drive the implementation of clinical deviation management and Serious Breach process...+ Lead complex quality investigations impacting the clinical trial delivery systems. + Provide Quality Leadership for… more
- Parexel (Boston, MA)
- **Job Title:** Data Management Lead (Medical Affairs) - Oncology **Location:** Fully Remote (US based) Must be able to accommodate West Coast hours. **About ... solutions. We are seeking a dynamic and experienced Data Management Lead to join our team. If...you will be doing:** **Responsibilities will include:** + Develop risk management strategies and proactively manage timelWhat… more