.Clinical Study Team Assistant II, FSP -The Clinical Study Team Assistant II (CSTA II) is an essential part of the Core Study Team and is responsible for driving and/or supporting key clinical trial tasks for assigned studies to ensure compliance with ICH-GCP, SOPs, and regulatory regulations. The role collaborates with global study team members and is responsible for multiple tasks that span from study start-up to study close-out which enables the efficient execution of clinical trials to high quality standards- Job DescriptionProvides study level operational support to the Core Study Team from study start up to close out and submission:- Management and oversight of Study Team shared spaces- TMF maintenance, compliance, and oversight- Analyze, interpret, and follow up on metrics- Management and oversight of Study Management Platform- Analyze, interpret, and follow up on metrics- Registry and/or Clinical Trial Management system(s) compliance and maintenance- Tracking and oversight of study level information; follow up with functional lines as needed- Liaising with cross functional study team members:- Provide study level reporting to support management of clinical trial data, clinical trial budget and timelines- Quality Control (QC) of essential clinical trial, Clinical Study Report (CSR) and regulatory submission documentation- Manages engagement of Independent Oversight Committees- Provides support to the CSTL and Clinical Quality Lead with Inspection Readiness Activities- Assists the CSTL with oversight and tracking of Clinical Trial Budget spend- Provides logístical/operational support to Study Management for Investigator Meetings- Provides status updates on key tasks and activities to the CSTL and contribute to the Core Study Team Meetings as an active Core Study Team member- Works proactively and independently to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes- Ensures the completion of assigned tasks according to timelines and to required quality standards- Serves as Subject Matter Expert or Technical Resource for key clinical trial processes, systems and tasks- On occasion, supports short term Clinical Operations Special Project requests (e.G
