Prior and proven Project Management in CRO setting
Oncology indications*** REQUIRED
Ideally global PM Ph I, II, or III
Nice to have –
Prior Pharma experience alongside CRO experience
Cell, gene therapy
study start up, interim analyses
experience with biotech accounts
Responsible for the overall coordination and management of clinical trials from start up through close out activities. Directs the technical and operational aspects of the projects, securing the successful completion of clinical trials. Works with major functional area leads to identify and evaluate fundamental issues on the project, interpret data on complex issues, makes sound business decisions and ensure solutions are implemented. Works to ensure all project deliverables meet the customers time/quality/cost expectations. Accountable for ensuring all project deliverables meet the customer/contract expectations, providing accurate hour forecasts, reviewing passthrough costs and ensuring timely invoicing with the support of Project Management Directors and/or Associate Directors while working in collaboration with other functional area leads. May work with Directors and/or Associate Directors, Project Management and Contracts & Proposals Development on the development of new proposals and general capabilities presentations to Customers for new business.
•Manages allocated studies according to timelines and quality standards. Coordinates activities of all functional departments and vendors involved in the project. Works with team and management to develop plans/guidelines for project implementation using PPD tools. Monitors and analyzes project status to ensure successful completion of project parameters, milestones, timetables (i.e., regulatory document, research agreement, site payments, interim monitoring, CRF retrieval, CRF data entry, etc.). Ensures teams are entering and updating internal tracking tools e.g. Project Pulse, CASCADE, etc. Works with team to identify potential risks, develop contingency plans.
•Acts as principal liaison between Sponsor and PPD by facilitating the flow of information between PPD and client. Provides Sponsor with timely project updates, project related fiscal information, ensures correct protocol interpretations, and obtains direction and feedback on implementing scope of work. May discuss and obtain feedback from Sponsors regarding PPDs performance to date.
•Plans and communicates to team members study specific tasks and priorities for projects. Delegates, as appropriate, assigned responsibilities to project team members. Liaises with managers in all functional areas within PPD to optimize performance and utilization of the project team members. Appropriately escalates any issues or potential issues to the Project Management Director or Associate Director for all project related issues.
•Works closely with finance and legal to manage all financial and contractual aspects of the study including establishing and recognizing financial milestones for invoice and subcontractor purposes, subcontracting with thirdparty service providers, approving subcontractor invoices, establishing proper accrual for investigator grants, assisting with negotiation of the investigator grants as needed and similar passthroughs. Works with the project team to establish appropriate controls to ensure that project resources and expenses are aligned
with budgets. Works closely with Project Management Director or Associate Director to provide details for the development and negotiation of contract modifications, as needed.
•Ensures that appropriate assessment and coordination of project/protocol specific and therapeutic area training needs and activities are occurring for the team members as needed.
•Provides input into hiring, performance management, training and other activities related to leading project staff members across functional areas.
•Works to prepare and present at client meetings as the assigned Project Manager. Attends bid defenses as necessary.