Manages the assigned clinical research project(s), ensuring the quality of deliverables on time and within budget.
Leads project teams, ensuring successful contract reviews, resource application and team training from study startup through conduct and study close.
Participates in project planning activities like staffing, budgeting, and cost prioritization and recommending and implementing changes to methods. Tracks planned activities and deliverables using project management tools.
Participates in developing and implementing risk mitigation strategies. Helps identify potential project issues and contributes to contingency plans.
Monitors status of planned activities and deliverables to keep project and resources on schedule
Provides technical and operational input to support team to ensure the project is run timely and in good quality.
Be a point of contact for the Sponsor and study team members including stakeholders and vendors.
Organize and lead meetings with clients and resolve conflicts that may occur between team members or with client team members under guidance.
Gains experience through project involvement and supervision by senior project managers. Focuses on building project management expertise and GCP compliance
Provides inputs for proposals during pre-award study and support Business Development team.
Work with Key Management team including CEO, Finance, HR, Procurement, Clinical Operations, Regulatory Affairs, Medical Science & Real World Evidence, Biometrics to drive company toward strategic directions.
Qualifications
Bachelor's degrees in pharmaceutical science, Health science, medical science or related fields are preferable.
Minimum of 5 years experience in clinical trials within a medical and/or healthcare research and development company.
Minimum of 1 year experience in project management and leadership role involving business and data analysis.
Knowledge of Thai and international laws governing clinical trials and health regulations.
Good understanding of project management principles.
Skills in resource management, resource forecasting, and budget analysis.
Familiarity with Good Clinical Practice (GCP) guidelines of the International Conference on Harmonization (ICH) or ICH GCP.
