Job Description :
Role: Project Manager with Infectious Disease exp
Location: 100% Remote (2 video interviews) (No WEST Coast, EAST coast Preferred)
Duration: 12-18mth+
VISA: US Citizen, GC

Looking for infectious disease ideally, but other therapeutic areas are ok if they have CRO experience. * Please do not resubmit candidates from other reqs - looking for a fresh batch of candidates for this assignment!

Responsible for the overall coordination and management of clinical trials from start up through to final deliverables. 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.
Manages allocated studies according to timelines and quality standards.
Coordinates activities of all functional departments and vendors involved in the
project; in some cases the multi functional project management lead will have to
take direct responsibility for the clinical subspecialty functional area. 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.
Education and Experience:
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, Skills and Abilities:
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.
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 organised, 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 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 knowledge/understanding of clinical development guidelines and directives.
Working Conditions and Environment:
Work is performed in an office/ laboratory and/or a clinical environment.
Exposure to biological fluids with potential exposure to infectious organisms.
Exposure to electrical office equipment.
Personal protective equipment required such as protective eyewear, garments and gloves.
Physical Requirements:
Ability to work in an upright and /or stationary position for 6-8 hours per day.
Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
Frequent mobility required.
Occasional crouching, stooping, with frequent bending and twisting of upper body and neck.
Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
Frequently interacts with others to obtain or relate information to diverse groups.
Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
Regular and consistent attendance.