.Job DescriptionProvides study level operational support to the Core Study Team from study start up to close out and submission with general direction:- 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 MeetingsProvides 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 with mínimal oversight to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes- Uses established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards- On occasion, supports short term Clinical Operations Special Project requests (e.G. workstreams, initiatives, projects)- Manages conflicting priorities to ensure excellent support to assigned study teams with general direction- Manages own time to meet agreed targets; develops plans for short-term work activities on own projects (timelines, work plans, deliverables)- Completes training assigned by Client and/or EP, as necessary, including general training requirements, SOPs, system, and process related training.- Adheres to EP and Client SOPs and processes**Education and Certification**:- Bachelor's Degree (B.S or B.A) with 0 to 3 years' experience or Master's Degree (M.S, M.A or M.B.A) with 0 to 1 years' experience**Skills and Experience**:- Relevant clinical research or clinical trial experience or relevant coursework in drug development or clinical research