Responsible for the overall coordination and management of clinical projects/studies from start-up through close-out activities. The CRPM II is responsible for the management of complex, multi-center, multinational clinical studies, including FDA-regulated clinical trials. Directs the technical and operational aspects of clinical research efforts, including providing supervisory and mentoring support to other clinical research staff, to ensure the successful completion of clinical studies. Manages complex relationships with a diverse group of collaborators representing donor agencies, local government, non-government organizations, industry, and academia. Works with major functional area leads to identify and evaluate fundamental issues on the project, makes sound business decisions and ensures solutions are appropriately vetted and implemented. Works to ensure all project deliverables meet the sponsor's time/quality/cost expectations. Works in collaboration with other functional area leads providing accurate labor forecasts, reviewing pass-through costs and ensuring timely invoicing. 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 or exceed 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.
- Coordinates assignment of needed resources for project conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals within budget.
- Develops budget and expense review strategy; creates scope definition documents and creates proactive cost containment strategies and communicates with project team; regularly reviews budget/expenses with project team.
- Ensures strong client relationship management through clear communications, decisive escalation of issues and coordination with other project leadership.
- Provides leadership and vision to all project staff and external vendors contracted to complete projects.
- Collaborates with leadership to set clear team and individual expectations to accomplish the goals set forth in the project charter and establish a clear link to department and organizational goals.
- Identifies needed project processes and oversees development of processes and training of project team in the knowledge/application of project processes.
- Leading problem solving and resolution efforts to include management of risk, contingencies and issue resolution.
- Manages the day-to-day operations of multiple clinical trials or a single complex trial, including trial start-up, conduct, and close-out activities.
- Develops and implements clinical operational plans, incorporating the study and scientific plans.
- 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 established and met.
- Serves as primary contact for sponsor(s) and/or functional area representatives in managing protocol development, review, approval, and 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.
- Oversees forecasting of clinical/non-clinical supplies.
- Ensures accuracy and timeliness of vendor and site payments.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
- Supports performance management and professional development of direct reports, including ongoing feedback, coaching, and career support.
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.
- Serves as team lead to team members.
- Typically reports to an Associate Director/Director.
- 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 utilize collaborative problem-solving approaches to mediate conflict and to establish and maintain effective working relationships with internal and external collaborators.
- Effective in presenting information and responding to questions from project teams, external vendors and clients.
- Prior experience and demonstrated success in working with Principal Investigators (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.
- A minimum of 8+ years of previous experience in clinical research project management, possessing the knowledge, skills, and abilities to perform this job.
- Minimum of 5 years of experience managing clinical studies in resource-constrained settings.
- Global project management experience.
- 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.
Technology to be Used:
- Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other handheld devices.
Typical Physical Demands:
- Typical office environment.
- Ability to sit and stand for extended periods of time.
- Ability to lift 5-50 lbs.
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