Project Manager

Role & responsibilities

Take primary responsibility for sponsor relationship and sponsor communication ensuring high sponsor satisfaction.

Project Initiation and Planning and Conduct feasibility studies.

Arrange the kick-off meeting, inviting a representative from each functional area involved, ensure the scope of the study is well understood by all functions and that the appropriate resorting will be delivered by the functions for assigned projects.

Ensure the project is progressing according to quality standards, SOPs, ICH-GCP and/or other guidelines to fulfill local regulations and is completed within budget, as per schedule and according to contract specifications.

Schedule meeting with study team to assess the progress of each individual project deliverable against project plan and budget. Assessing the overall status of the project and resources needed for next project deliverables.

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.

Track timelines, milestones and budget requirements for assigned projects

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

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

Develop appropriate study tools and tracking systems for study execution

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

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

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

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

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.

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

Assist and guide CRA Managers/CRA's in conducting pre-study, initiation, interim and closeout monitoring visits as required

Review and approve payments to the study site and vendors and prepare budget forecasts and reports for assigned projects

Ensure effective communication between Stake holders and all project team members

Identify and Screen new sites and PIs and Create Data Base of New potential PIs and sites