Work Schedule
Standard (Mon-Fri)

Environmental Conditions
Office

Job Description

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.

• 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.
• Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job.
• Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

• 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.

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Able to work in non-traditional work environments.
• Able to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May have exposure to potentially hazardous elements typically found in healthcare or laboratory environments.
• This role requires independent travel up to 20%, inclusive of traveling in automobiles, airplanes, and trains.