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.
**Preferred Qualifications**:
- Science background
- Effective verbal and written communication skills
- Ability to work independently but also as part of a larger team with limited support from supervisor
- Ability to multitask and manage multiple competing priorities - Has fundamental knowledge of the principles and concepts related to the CSTA role
- Self-motivated and ability to organize tasks to ensure timelines are met and deliverables are of high quality
- Knowledge of drug development process
- Attention to detail evident in a disciplined approach to document review, adherence to SOPs, metrics, etc.
- Good problem solving & decision-making skills: Ability to work in ambiguous situations within the team to identify and resolve complex problems; Seek input from others when faced with a difficult situation; Make sound decisions within the scope of responsibility; Focus on resolving problems
**Language Skills**:
- Proficiency in written and spoken English
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📌 Clinical Study Team Assistant I - Fsp (México)
🏢 Parexel
📍 México