Project Manager

Job Title: Project Manager
Location: Ahmedabad
Department: Clinical Operations Department
Experience: 12 Years
Qualifications: M Pharm, Ph.D., BDS, MBBS
Special Skills: Project Planning, Team Management

Key Responsibilities:
1-Sponsor Relationship Management
Take primary responsibility for sponsor relationships and communications, ensuring high sponsor satisfaction.

2-Project Initiation & Planning
Conduct feasibility studies, arrange project kick-off meetings, and ensure clear understanding of the study scope across all functional areas.

3-Project Progress Monitoring
Monitor project progress to ensure adherence to quality standards, SOPs, ICH-GCP, and local regulations, completing the project within budget and on schedule.

4-Project Team Coordination
Schedule meetings with the study team to assess the progress of individual deliverables, and allocate necessary resources for next steps.

5-Project Plan Development
Develop and maintain a comprehensive project plan, tracking timelines, milestones, and budget requirements.

6-Develop a project plan, including all elements listed in the project plan template as appropriate for the project and identify the scope of improvements in Project Management Team for quality deliverables.

7-Track timelines, milestones and budget requirements for assigned projects

8-Coordinate internal and external clinical development activities of all team members involved in the design and conduct of assigned clinical trials.

9-Allocate CRA Managers/CRA's for clinical research projects.

10-Develop appropriate study tools and tracking systems for study execution

11-Assist new CRA Managers/CRA's in identifying and developing investigators for assigned studies

12-Coordinate and Plan for the proper conduct of projects in liaison with CRA Managers/CRA's and Communicate project related and manpower requirement to Head Clinical Operation

13-Assist in the selection of sites in conjunction with the sponsor and Veeda and recommend site assignments.

14-Provide protocol specific training to the CRA Managers/CRA's including therapeutic expertise, CRF conventions, study procedures and SOPs

15-Supervise activities of the CRA Managers/CRA's including the scheduling of monitoring visits, other activities associated with the project (e.g., review of visit reports for completeness and accuracy, assisting monitors with problem sites, etc.), and time accountability for the project.

16-Conduct co-monitoring visits with CRA Managers/CRA's to ensure quality and compliance with SOPs, GCPs and project requirements