Piotr Rzytki

• Prepare draft project plan including all sub plans (Communication plan, Risk Management plan, MSP, WSOP listing, Quality plan, Central Files Maintenance Plan, etc.) for team discussion before Kick-off meeting
• Prepare project documents and status reports for Project Manager
• Prepare study recruitment plan in co-operation with SMO (Site Management Organization) which outlines key recruitment challenges for the trial and corresponding strategies to meet the milestone, monitor compliance to the plan and report status to Project Manager
• Responsible for assigned tool management including set up and maintenance of the recruitment planning tool in co-operation with SMO; maintain investigator /supplier portal
• Initiate, set-up and maintain Management Systems on a regular basis
• Develop routine Client Report format with Functional Leads using standard reports where possible, may be involved with ad hoc client requests for reporting
• Arrange project related training for (new) project team members under the direction of the Project Manager maintain project specific trainings overview and records including study specific system training and access for PI, (new) site staff, study team and new study team members (e.g. IVRS, e-CRF)
• Attend project specific training as required and per SOP and Work Instructions
• Oversee implementation of Quality Plan, perform Project Management related quality checks on the study according to Quality Plan and in close co-operation with Project Manager (e.g. Study Manual, CRF completion guidelines)
• Support Project Manager in identifying, implementing, reviewing and up-dating project specific operational performance metrics
• Support Project Manager in appropriate selection of third party suppliers, manage internal procurement process, ensuring that appropriate Scope of Work documents and Purchase Requisitions are in place
• Co-ordination for vendors to answer queries, provide study updates, report and trackers if required
• Work with Project Manager and Project Financial Analyst to develop “what if” scenarios to ensure pro-active decisions and solutions
• Document Lessons Learned and post in Lessons Learned database
• Communicate with the client on specific items as directed by the Project Manager
• Manage the project resourcing – resource requests
• Support projects for in-house audits
• Provide internal support to Project Manager as a project resource supporting internal systems and systems set-up but also executing day-to-day data analysis of the operational study status (planned versus current) and reporting activities
• Support Project Manager in set up of a study specific payment procedure, where required. Ensure investigator information and payment details are entered in the CTMS, administer investigator payments; track payments, ensure timely processing and secure all approvals as needed