Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics
8 hours ago
Analytical Instruments • Laboratory Supply Chain Programs and eCommerce • Laboratory Equipment • Lab Services • Specialty Diagnostics
• 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 customer’s time/quality/cost expectations. • Accountable for ensuring all project deliverables meet the customer/contract expectations, providing accurate hour forecasts, reviewing pass-through 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. • Essential Functions: 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 PPD’s 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 third-party service providers, approving subcontractor invoices, establishing proper accrual for investigator grants, assisting with negotiation of the investigator grants as needed and similar pass-throughs. • 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.
• Bachelor's degree or equivalent and relevant formal academic / vocational qualification. • Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years’) or equivalent combination of education, training, & experience. • Knowledge of the key principles of cross functional project management (Time, Quality, Cost). • Solid financial acumen. • Applies a range of negotiation techniques to achieve desired outcomes with evidence of commercial and organizational acumen. • Can effectively plan and deliver a dynamic and persuasive presentation, using effective graphics, overheads or slides. • Displays effective communication skills (listening, oral, written) and can communicate in English language (oral, written). • Sound interpersonal skills, is flexible and adapts to changing situations. • Has the ability to persuade, convince, and influence or impress others. • Is organized, proficient at multi-tasking with good attention to detail. • Able to lead, motivate and coordinate teams. • Coach/mentor team members as appropriate. • Able to delegate, effectively prioritizes own and workload of project team members. • Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, etc. • Possesses cross cultural awareness and is able to adapt appropriately. • Has an in-depth understanding and appreciation of clinical research/development, including medical and therapeutic areas, phases and medical terminology. • Has experience with leading, liaising and coordinating cross-functional project teams. • Has an in-depth knowledge/understanding of clinical development guidelines and directives.
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