Project Manager

Role & responsibilities

Overall responsible to supervise clinical research department activities including mentoring CRAs and CTAs.

Acts as point of contact for communication between the internal team and external parties (i.e. sponsor, central lab, PI)

Providing inputs for study protocol, ICF and CRF

Presenting kick off meeting and project training to team members

Organizing (facilitate) and attending Investigators Meeting.

Coordinator with In-house / Vendor / Pharmacist for IMP supply and shipments

Coordinate and distribute clinical study material to study sites

Perform Site Identification and conduct feasibility studies

Co-ordinate with sites for Ethics Committees Submission

Perform SSV, SIV, SMV and SCV in timely manner

Preparation and review of Clinical Monitoring Plan and Project Management Plan

Review of Data Management Plan and Investigational Management Plan

Review of monitoring reports prepared by CRAs

Internal QC of study files/ documentation

Updating about the trial status, such as investigator, site, SAE reporting and SCV

Maintain and updating site files (TMF and SMF) and collection of essential documents

Training and delegation of duties to new joiner

Archival of study documents

Preparation and Review of SOP

Preparation and planning of activities during audit/inspection

Any other additional activities assigned by Head of the department.