FHI360 Manager, Global Site Management (FHI Clinical) in Salt Lake City, Utah
Summary of the position:
The Manager, Global Site Management is responsible for the direct line management of Site Start Up Staff; Site Maintenance Associates including training, resourcing, performance evaluation and career development. In addition, the Manager, Global Site Management has oversight of site recruitment, contract management, site initiation, oversight of site essential documents during the life cycle of a trial, and execution and completion of study deliverables according to contractual agreements.
Manages staffing and resources to ensure departmental utilization
Drives study start up teams to meet project timelines
Assists in determining efficiencies for study start up to continually improve and streamline current processes without compromising quality
Assists in determining efficiencies for essential document maintenance to continually improve and streamline current processes without compromising quality
Assists in proactively moving the department forward through involvement of corporate initiatives
Performs additional duties and assignments as requested
Performs all aspects of managing/mentoring direct reports for HR items, training and performance management
Manages and motivates direct reports with project and people management responsibilities
Creates and evaluates performance objective for direct reports and completes performance evaluation for direct reports for annual appraisals
Prioritizes multiple assignments in a fast-paced work environment
Maintains spreadsheets regarding metrics and provides monthly updates to upper management or as needed
Applies analytic skills to reports and feasibility in the Study Planning stage
Works within an organized and highly developed problem-solving environment
Maintains working knowledge of costing for tasks involved with Study Start Up and sourcing staff
Recommends measures to reduce costs for FHI Clinical, when appropriate
Contributes to aspects of business development, including evaluating and defining proposal specifications
Presents to clients as needed or required
Utilizes technology in search capabilities for Study Planning
Ensures department staff is current on company SOPs as well as updates to industry regulations and guidelines
Meets with staff regularly to ensure that studies are on target to meet timelines
Manages resourcing and staffing of new studies awarded to FHI Clinical to ensure that studies are adequately staffed, and timelines are met
Prepares forecasts for staff utilization over the life of the study
Ensures appropriate transition planning and stakeholder communication for any staff changes
Provides Time Entry Guidelines to the clinical staff and applicable training
Identifies out-of-scope tasks from the clinical team and ensures pre-approval of these tasks
Reviews and advises on Regulatory and Clinical Operations SOPs, ADs, and Job Aides related to study start-up
Mentors staff, as applicable, and works closely with staff for career pathing to ensure growth in the company as desired
Participates in corporate initiatives and actions that ensure the continued success of the company
Acts as a resource for other Managers and seek opportunities to share knowledge base
Recognizes strategic opportunities to improve department productivity
Develops training and implementation for own staff, as well as other departments
Produces succinct documentation and presentation for both internal and external use with minimal input from upper management
Establishes harmonized process for site recruitment, study start up, maintenance and close out
Knowledge, skills and abilities:
Needs an in-depth level of understanding of the conduct of clinical trials, related systems, and procedures, and guidance and regulations.
Knowledge of ICH/GCP Regulations
Working knowledge of FDA Guidance Documents / EU Directives / Local Regulations / ISO14155 regulations, drug / device development, and clinical monitoring procedures
Knowledge of web-based communication tools for conferences and any other IT systems required for the job
Knowledge of national/local health systems as well as knowledge of cultural/professional practices appropriate to the country/region where the site start up activities will be carried out
Basic knowledge of the principals of project management
Driven self-starter with the ability to begin tasks independently and complete tasks without supervision; Works independently as well as part of a team in a global capacity
Must have excellent interpersonal and communication skills and demonstrate the ability to work successfully in a team environment.
Ability to prioritize and manage multiple tasks with demonstrated ability to meet deadlines in a fast-paced environment with changing priorities.
Demonstrated effective organizational skills and strong attention to detail.
Possess an understanding of medical and clinical research terminology.
Maintains a positive, results orientated work environment
Previous experience with database and clinical management systems.
Strong written and verbal communication skills.
Customer service focused in approach to work, both internally and externally
Ability to establish and maintain effective working relationships with coworkers, managers and clients.
- Undergraduate degree or its international equivalent in clinical, science, or a health-related field from and accredited institution; a licensed health-care professional (i.e. registered nurse); or equivalent work experience required
Preferred Job-related Experience:
Minimum of 5 years’ experience, in a regulatory affairs, clinical research, or clinical operations environment.
1+ years people management experience
Study Start Up experience
Clinical Monitoring Experience (on-site and/or remote)
Proficiency in Microsoft Office, spreadsheets, and SharePoint required.
Articulate, professional and able to communicate in a clear, positive fashion with clients and staff.
Ability to work independently without direction.
Ability to adapt to fast paced environment requiring flexibility and task prioritization
Must be able to read, write and speak fluent English.
Additional Eligibility Qualifications:
Experience with Trial Master File (TMF)
Experience with Clinical Trial Management Systems (CTMS)
Experience with Electronic Data Capture Systems (EDC)
Master’s degree or its international equivalent preferred.
Related prior work experience required.
Special Position Requirements: None
- Typical office environment. Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.
Expected travel time is less than 25% 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 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.
Please click here to continue searching FHI 360's Career Portal.FHI 360 is an equal opportunity and affirmative action employer. FHI 360 is an equal employment 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, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.
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.
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