FHI 360’s Product Development and Introduction team leads development and testing of a portfolio of new contraceptive leads with a focus on long-acting methods. The team consists of 30+ contraceptive development professionals with expertise in reproductive biology, gynecology, chemistry, epidemiology, and clinical trial and project management. We are currently seeking qualified candidates for the position of Clinical Research Project Manager I.
Responsible for the overall coordination and management of clinical projects/studies, including FDA-regulated 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.
- Coordinates assignment of needed resources for project conduct and completion with functional area leaders; ensures appropriate staffing to accomplish project goals.
- Ensures that trial timelines, costs, and quality metrics are met.
- Establishes study milestones and ensures accurate tracking and reporting of study metrics.
- Leads problem solving and resolution efforts to include management of risk, contingencies and issue resolution.
- 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
- 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.
- Supports performance management and professional development of direct reports, including ongoing feedback, coaching, and career support.
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 working with PIs and research coordinator teams.
- 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.
- Typically supervises two or more clinical operations staff.
- Master's Degree or its International Equivalent • Health Professions and Related Clinical
- 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.
- Preferably has 5+ progressive years in Clinical Operations within Pharma/Biotech/CRO
- Knowledge of EDC, eTMF, FDA regulations and ICH GCP.
- Preferably has experience managing direct reports.
- Proficiency in Microsoft Office, and spreadsheets required.
- Able to delegate and effectively prioritize workloads and project team members.
- Displays effective communication skills (listening, oral, and written) and can communicate in the English language (oral, written).
- Has experience developing key study documents including clinical monitoring plans, project management plans, study manuals and clinical trial agreements.
- Has experience writing requests for proposals and evaluating vendor budgets and proposals.
- Has familiarity with preparation for vendor, site and sponsor audit activities.
- 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.
Typical Physical Demands:
- Typical office environment.
- Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.
Technology to be Used:
- Personal Computer, Microsoft Office (i.e. Project, Word, Excel, PowerPoint), e-mail, telephone, printer, calculator, copier, and cell phones.
Location: US based - NC or remote
**Or an equivalent combination of relevant education and/or experience sufficient to successfully perform the key responsibilities of the job. This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
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About FHI 360
FHI 360 is an international nonprofit working to improve the health and well-being of people in the United States and around the world.
We partner with governments, the private sector and civil society to bring about positive social change and to provide lifesaving health care, quality education and opportunities for meaningful economic participation. We do this by using research and evidence to design and deliver innovative programs that change behaviors, increase access to services and improve lives.
Our staff of more than 4,000 professionals work in more than 60 countries. Their diverse technical expertise and deep understanding of local conditions provide a 360-degree perspective that allows us to develop customized responses to the toughest human development challenges.