Manage and co-ordinate efforts of cross-functional project teams to support milestone achievement and to manage study issues and obstacles.
Ensure consistent use of study tools and training materials and compliance with standard processes, policies and procedures.
Arrange and participate in investigator meetings and liaise with vendors to facilitate the smooth conduct of the same.
Identify and manage vendors in accordance with Sponsor SOPs, GCP and Local Regulatory Guidelines for study specific deliverable (including but not limited to; Clinical Trial Management System, Study Equipments, Travel Arrangements, Couriers, etc.) in delegated projects.
Develop study management plans and generate tools to facilitate tracking of performance at project level.
Serve as primary point of contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to.
Identify quality issues within the study to implement appropriate corrective action plans. Escalate findings and action plans to appropriate parties (Senior Management / Sponsor/ Data Management/ Medical Writing/ Stats, etc.).
Liaise with study team and facilitate (if required) selection of Investigator/ site as well as assist in Contract development and setting up the Investigator payment procedures for designated studies. In absence of team members, ensure the Investigator/ site payments are processed as per the agreed timelines in the executed contract.
Provide inputs for the development of proposals for new work and manage project budgets.
input to line managers of their project team members performance relative to project tasks.
Prepare and present project information at internal and external meetings.
Participate in proposal development and in the bid-defence process with guidance and supervision
co-monitoring/accompanied site/visits and ongoing mentoring of CRA team.