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Clinical Study Team Assistant I, FSP

hace 2 meses

San Cristóbal de las Casas, Chiapas, México Parexel A tiempo completo
Job Summary

We are seeking a highly organized and detail-oriented Clinical Study Team Assistant I to provide operational support to our Core Study Team. The successful candidate will be responsible for managing study level information, tracking metrics, and ensuring compliance with regulatory requirements.

Key Responsibilities
  • Provide study level operational support to the Core Study Team, including management of study level information and tracking of metrics.
  • Manage and oversee Study Team shared spaces, including TMF maintenance and compliance.
  • Analyze and interpret metrics, and follow up on any discrepancies.
  • Manage and oversee the Study Management Platform, including analysis and interpretation of metrics.
  • Ensure compliance with regulatory requirements, including registry and/or Clinical Trial Management system(s) maintenance.
  • Liaise with cross-functional study team members to provide study level reporting and 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.
  • Manage engagement of Independent Oversight Committees and provide support to the CSTL and Clinical Quality Lead with Inspection Readiness Activities.
  • Assist the CSTL with oversight and tracking of Clinical Trial Budget spend and provide logistical/operational support to Study Management for Investigator Meetings.
  • Provide 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.
  • Work proactively with minimal oversight to coordinate and prioritize multiple key study tasks in support of clinical trial systems and processes.
  • Use established procedures and methodologies to ensure the completion of assigned tasks according to timelines and to required quality standards.
  • On occasion, support short-term Clinical Operations Special Project requests (e.g. workstreams, initiatives, projects).
Requirements
  • 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.
  • Strong organizational and time management skills, with ability to prioritize multiple tasks and meet deadlines.
  • Excellent communication and interpersonal skills, with ability to work effectively with cross-functional teams.
  • Ability to analyze and interpret data, and make sound decisions based on findings.
  • Knowledge of clinical trial regulations and guidelines, including ICH GCP and 21 CFR Part 11.
About Parexel

Parexel is a leading global biopharmaceutical services company, providing a broad range of solutions to help clients accelerate and improve their development and commercialization of new and existing products.