The Clinical Research Project Manager I (CRPM) will be a senior member of the COVID-19 Prevention Network (CoVPN) Operation Center team responsible for the project management of high-profile clinical studies related to COVID-19 prevention from start up through close out activities. They will oversee partnerships with pharmaceutical companies, government agencies and contract research organizations in order to advise the technical, operational and staffing resources required to ensure the successful completion of clinical trials. The CRPM must have solid understanding of the critical elements of clinical trials, and will be expected to coordinate these elements, including, but not limited to, protocol development; regulatory requirements; data management and statistical support; study product management and administration; clinical and safety monitoring; budgeting and procurement; study implementation and community engagement. Able to effectively create operational project plans tailored to the needs of each assigned study, including methods to monitor study progress. Working in collaboration with internal and external functional leads, the CRPM will identify and evaluate fundamental issues, make good business decisions, and ensure solutions are implemented. In addition, they will be able to provide accurate labor forecasts, review pass-through costs and ensure timely invoicing. Ultimately, the role of the CRPM is to ensure that high-quality clinical trial deliverables are completed on time, within budget and in accordance with all applicable policies and procedures.
- Leads and coordinates all critical elements of clinical research studies, including project planning, budget, and resource management.
- Serves as primary contact for partner, sponsor and/or functional area representatives in running clinical trial execution.
- Develops and implements clinical operational plans, incorporating the study and scientific plan.
- Establishes study milestones and ensures accurate tracking and reporting of study metrics.
- Ensures that trial timelines, costs, and quality metrics are met.
- Manages staff conducting the day-to-day operations of multiple clinical trials, including trial start-up, conduct, and closeout activities.
- Coordinates forecasting of technical, operational and staffing resources.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
- Performs ongoing vendor management including independent negotiation of scope of work, budgets, performance management, and issue resolution.
- Ensures accuracy and timeliness of vendor and site payments.
- Recommends and implements innovative process ideas to impact clinical trials management.
Applied Knowledge & Skills:
- Prior experience and demonstrated success in providing project management for clinical studies is required.
- Organized, proficient at multi-tasking with exceptional attention to detail.
- Able to lead, empower and coordinate teams.
- Able to work efficiently in a horizontal matrix managing partners and alliances.
- Ability to successfully use automated systems and computerized applications such as MS Office programs and project management systems.
- Possesses cross cultural awareness and is able to adapt appropriately.
- Knowledge of the key principles of cross functional project management (Time, Quality, Cost).
- Can optimally 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.
- Establish and maintain systems and processes vital to control and report trial status and activities.
- 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.
- May report to a manager or director.
- Master's Degree or its International Equivalent in a health profession or related clinical sciences
- PhD in biological sciences preferred.
- Project Management (PM) Certification preferred.
- Requires a minimum of 5+ years of previous experience in clinical research project management in the pharmaceutical/biotech/CRO industry, possessing the knowledge, skills, and abilities to perform this job.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams, etc) and experience with project management software (eg Microsoft Project, Monday.com) required.
- Specialist in ICH Good Clinical Practice (GCP), with knowledge of electronic data capture (EDC), electronic Trial Master File (eTMF), FDA regulations and clinical data management
- Able to delegate and prioritize their own workload and workload of project team members.
- Displays effective communication skills (listening, oral, and 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.
- Able to read, write and speak fluent English.