FHI360 Clinical Research Project Manager II (FHI Clinical) in Helena, Montana
Summary of the position:
Responsible for the following objectives:
Successful implementation of up to four complex multi-center clinical projects, including FDA-regulated clinical trials, through all phases from start-up through close-out
Careful planning of the project lifecycle according to the Project Management Institute Global Standard
Appropriate direction of the activities of Clinical Research Associates, Clinical Trial Associates, Associate Project Managers, and subcontractors to execute the technical and operational aspects of clinical research projects and ensure the successful completion of clinical studies
Active management of complex relationships with a diverse group of collaborators representing donor agencies, local government, non-government organizations, industry, and academia.
Accurate identification and evaluation of project risks and development of appropriate mitigation plans early in the project lifecycle
Quality-focused approach to project deliverables, client interactions, risk mitigation, and fiscal management
Accurate planning, close monitoring, and proactive management of project budgets and contracts
Ensures appropriate staff resources are available to accomplish project goals within budget
Ensures project staff are appropriately trained for their project-specific roles and are aware of their project-specific responsibilities
Coordinates with executive leadership to balance project-specific resource needs and company-wide needs
Develops project budget and forecasts monthly expenses on a quarterly or bi-annual basis
Reviews budget/expenses with finance team and project team and develops mitigation strategies for potential overruns and underruns
Ensures accuracy and timeliness of vendor and site payments
Creates scope of work for subcontractors and defines and monitors roles and responsibilities for the FHI Clinical project team
Actively manages client relationships through clear communication, proactive thinking and problem-solving, and decisive escalation of issues
Monitors vendor/subcontractor performance to ensure quality deliverables, reasonable costs, and healthy client relationships
Provides leadership and vision to project staff and external vendors
Ensures that all project plans and documentation are complete, accurate, and being followed by study team members
Takes the lead on resolving all project emergencies and crises, and acts as the primary communicator to all parties during crisis management
Provides close oversight of daily operations of up to four clinical research projects and provides monthly updates to site management and project management directors
Recommends and implements innovative process ideas to impact clinical trials management
Supports performance management and professional development of direct reports, including ongoing feedback, coaching, and career support
Knowledge, skills and abilities:
Excellent organizational skills with exceptional attention to detail
Able to lead and motivate project teams
Mastery of routine office software packages (Outlook, Excel, Word) and proficiency in project management software (Microsoft Project, Basecamp, Podio, Asana, etc.)
Highly effective in cross-cultural settings
Mastery of the principles of project management in a matrix environment
Excellent public speaker with ability to 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
Excellent writing and speaking ability
Ability to delegate and prioritize workloads
Has 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 in writing and verbally
Able to read, write and speak English fluently
Education: master’s degree and 8 years of relevant experience or bachelor’s degree and 12 years of relevant experience
Required Job-related Experience:
Prior experience and demonstrated success in working with Principal Investigators (PIs) and research coordinator teams
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
Preferences: fluency or proficiency in any of the following languages: French, Spanish, Portuguese, Chinese, Thai, Vietnamese, Urdu or Hindi; clinical research or project management certification or online coursework
Special Position Requirements: ability to travel to and perform effectively in low-resource settings
Typical office environment: Personal Computer, Microsoft Office (i.e. Word, Excel, PowerPoint, etc.), e-mail, telephone, printer, calculator, copier, cell phones, PDAs and other hand-held devices.
Ability to sit and stand for extended periods of time.
Ability to lift 5-50 lbs.
Expected travel time is less than 10 % for this position
This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change, or new ones may be assigned with or without notice.
FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.
This job posting 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 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
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FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.
As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.
FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.
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