26 ene
Parexel
Nuevo Casas Grandes
.Provides 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 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 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
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