Clinical Research Project Manager
FHI 360, United States
Closing Date for Applications:
Responsible for the overall coordination and management of clinical projects/studies from start up through close out activities. Directs the technical and operational aspects of the projects, ensuring the successful completion of clinical projects/studies. Works with major functional area leads to identify and evaluate fundamental issues on the project, make good business decisions and ensure solutions are implemented. Works to ensure all project deliverables meet the sponsor's time/quality/cost expectations. The CRPM works in collaboration with other functional area leads providing accurate labor forecasts, reviewing pass through costs and ensuring timely invoicing. S/he effectively creates operational project plans tailored to the particular needs of each assigned study. Collaborates with centralized, remote monitoring units to ensure project progress and deliverables meet contractual requirements. Ensures that all clinical study management and project deliverables are completed to the Sponsor's satisfaction, ensuring quality deliverables on time and within budget and in accordance with Standard Operating Procedures (SOPs), policies and practices.
- Manages the day-to-day operations of multiple clinical trials, including trial start-up, conduct, and closeout activities.
- Develops and implements clinical operational plans, incorporating the study and scientific plan.
- Creates and manages overall operation of the entire clinical study including project planning, budget, and resource management.
- Ensures that trial timelines, costs, and quality metrics are met.
- Establishes study milestones and ensures accurate tracking and reporting of study metrics.
- Serves as primary contact for sponsor and/or functional area representatives in managing protocol execution.
- Performs ongoing vendor management including independent negotiation of scope of work, budgets, performance management, and issue resolution.
- Recommends and implements innovative process ideas to impact clinical trials management.
- Oversee forecasting of clinical/non-clinical supplies.
- Ensure accuracy and timeliness of vendor and site payments.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
Applied Knowledge & Skills:
- Organized, proficient at multi-tasking with exceptional attention to detail.
- Able to lead, motivate and coordinate teams.
- Ability to effectively use automated systems and computerized applications such as Outlook, Excel, Word, Project, etc. *Possesses cross cultural awareness and is able to adapt appropriately.
- Knowledge of the key principles of cross functional project management (Time, Quality, Cost).
- Can effectively plan and deliver a dynamic and persuasive presentation, using effective graphics, or slides.
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics.
- Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Effective in presenting information and responding to questions from project teams, external vendors and clients.
- Prior experience and demonstrated success in working with PIs and research coordinator teams required.
- Ability to establish and maintain systems and processes necessary to control and report trial status and activities.
- Ability to ensure that quality, regulatory-compliant clinical projects are conducted on time and within budget.
Problem Solving & Impact:
- Works on problems of diverse scope that require analysis or interpretation of identifiable factors.
- Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
- Decisions may affect a work unit or area within a department.
- Ability to read, interpret and develop clinical protocols and all associated materials. Ability to write clinical reports, protocols, business correspondence, and procedural manuals.
Supervision Given / Received:
- Provides suggestions on business and operational decisions that affect the department. *May serve as team lead to team members. *Typically reports to a Manager.
- Associate degree required.
- Master's Degree or its International Equivalent in Health Professions and Related Clinical Sciences preferred.
- Project Management (PM) Certification preferred.
- 3 years of previous experience in clinical research project management, possessing the knowledge, skills, and abilities to perform this job.
- Proficiency in Microsoft Office, and spreadsheets required.
- Able to delegate, effectively prioritizes own and workload of project team members.
- Displays effective communication skills (listening, oral, and written) and can communicate in the English language (oral, written).
- Possesses sound interpersonal skills, is flexible and adapts to changing situations.
- Articulate, professional and able to communicate in a clear, positive concise manner with sponsors and staff.
- Must be able to read, write and speak fluent English.