Local Study Associate Director/Clinical Trial Manager

Position Details

Major responsibilities:

  • Overall responsibility for project delivery in term of commitment, budget and time within the country
  • Contribute to patient recruitment strategy including regular communication with concerned Investigators as necessary. Proactively identify and resolution of study problems and issues.
  • Lead and optimize the performance of the local Study Team(s) at country level ensuring compliance with AZ SOPs, ICH-GCP and local regulations
  • Selection of potential Investigators considering capability, competence, etc., of the Hospitals/sites.
  • Ensure timely start-up of project from EC/IRB and Thai FDA submission to site initiation
  • Perform co-monitoring & QC visits with study monitor(s)
  • Organize regular Local Study Team meetings on an agenda driven basis
  • Ensure completeness of the Trial Master File
  • Ensure accurate payments related to the study are performed.
  • Participate in training and coaching new members of the Local Study Team ensuring compliance with ICH/GCP and AZ Procedural Documents.
  • Ensure that all study documents are ready for final archiving and sign-off completion of local part of the Study Master File.
  • Plan and lead activities associated with audits and regulatory inspections in liaison with Clinical Process Manager and QA.
  • Prepare and maintain study budget at country level
  • Provide regular information to Line Managers at country level on studies and planned study milestones/key issues.


Minimum Requirements and Preferred Background:

  • Minimum University degree, preferred in Pharmacy or healthcare-related field.
  • Minimum 5 years’ experience in Clinical Operations
  • Excellent knowledge of spoken and written Thai and English.
  • Good ability to learn and to adapt to work with IT systems.
  • Good project management, decision-making, coaching, interpersonal, negotiation skills.
  • Excellent communication skills, verbal and written and presentation skills.



Skills
Toxicology
Clinical Operations
Negotiation
Coaching

Functions
Other
Other

Job Overview

Job Type:

Hybrid


Company

AstraZeneca plc logo

AstraZeneca plc

38 active jobs

Industry:

Healthcare & Pharmaceutical

Ready to Apply?

Submit your application now and take the next step in your career journey.