Senior Project Manager

ORGANISATIONAL OVERVIEW

JOB DETAILS

• Prepare project plan as per the project timelines, budget and deliverables.
• Complete the assigned project in Qualitative, cost effective and time bound manner.
• Develop the contract and budget for clinical trial projects.
• Conduct feasibility studies.
• Track timelines, milestones and budget requirements for assigned projects
• Coordinate for the required regulatory submission and approvals for the conduct of the study and CTRI registration.
• Allocate CTA’s/CRA’s to clinical trial projects.
• System enhancement in terms of developing appropriate study tools and tracking system.
• Assist new CRA’s in identifying and developing investigators for assigned studies.
• Co-ordinate planning and conduct of clinical trial projects in liaison with CTA’s/CRA’s and other interdepartmental team members.
• Assist in selection of the sites in conjunction with sponsor and lambda and recommend site assignments.
• Provide protocol specific training to the CTA’s/CRA’s including therapeutic expertise, CRF conventions, study procedures and SOP’s
• Supervise activities of the CTA’s/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 site problems etc and time accountability for the project).
• Conduct quality control and co-monitoring visits with CRA’s to ensure quality and compliance with SOP’s, GCP and project requirements. Assist and guide CRA’s in conducting pre study, initiation, interim and close out monitoring visits as required.
• Review and approve payments to the study site and vendors.
• Prepare reports and updates for sponsor.
• Ensure effective communication between stake holders and all project team members.
• Guide the software team in developing e-CRF.
• Identify and screen newer sites and PI’s.
• Identify the improvement areas in project management team
• Create database of new PI’s and sites.
• Any other responsibilities as assigned by the Supervisor/HOD/Management.

KEY DELIVERABLES

ALLIED RESPONSIBILITIES

EXPERIENCE

EDUCATIONAL QUALIFICATION

MSc, Mpharm, Bpharm, BAMS, BHMS, Dentist or similar from medical science background.

COMPETENCIES