Associate Director
Job Responsibilties:
· Serve as International Project Manager.
· Manage interdisciplinary clinical research projects, as project manager, leading the clinical team to ensure on-time and on-budget perfomance.
· Recruit investigators and negotiate study budgets and contracts.
· Review and approve regulatory and other documents from investigator sites.
· Review and develop protocols and case report forms (CRFs).
· Plan, Coordinate, and present at Investigator's meetings.
· Participate in potential meetings with potential clients.
· Review Serious Adverse Events (SAE) reports.
· Review and approve monthly client invoices.
· Prepare project management reports.
· Review and approve monitoring trip reports.
· Review tables and listings generated from study data.
· Author Clinical Study Reports Supervise, train, and mentor the clinical staff on monitoring, SOPS and procedures.
· Mentor Senior CRAs and Managers on project management procedures and policies.
Required Skills:
· Bachelor's Degree or RN.
· For those with Bachelor's Degree or RN, eight years experience in clinical research, data management, regulatory affairs; with atleast 4 years experience in the monitoring and management of clinical research projects, (or) six years of (total) relevant experience with a relevant advanced degree.
· Ability and willingness to travel up to 20% of the time.
· Excellent written and oral communication skills.