FHI 360 staff working in the United States are required to be fully vaccinated for COVID-19, regardless of the type of project or client they serve, or of their employment status (full/part-time, remote, telework, or in-office), unless an accommodation applies. FHI 360 complies with federal, state, and local laws with regard to accommodations related to this policy. Full vaccination is currently defined as two weeks after the second dose in a two-dose series, such as the Pfizer-BioNTech or Moderna vaccine, or two weeks after a single-dose vaccine, such as Johnson & Johnson’s Janssen vaccine. Booster doses are not required at this time.
The Infectious Diseases Clinical Research Consortium (IDCRC) is a NIH award to support the planning and implementation of clinical research that addresses the scientific priorities of NIAID in evaluating vaccines, other preventive biologics, therapeutics, diagnostics, including prognostics and predictive markers, and devices or the treatment and prevention of infectious diseases. Although the scientific focus will be on malaria/neglected tropical diseases, sexually transmitted infection, respiratory infection and enteric diseases, the Leadership and associated Vaccine Trial Evaluation Units (VTEUs) will work collaboratively to monitor, identify and adjust research priorities based on potential emerging infectious diseases, to include current COVID research. (VTEUs are the companion to the IDCRC LG Award. The VTEUs provide the infrastructure, scientific and administrative expertise to implement the clinical research.)
FHI 360 has partnered with Emory University to participate in leadership activities and serve as the Protocol Management Center for IDCRC driven research, leading study development and implementation under the direction of the Division of Microbiology and Infectious Diseases (DMID) of the U.S. National Institute of Allergy and Infectious Diseases. The Clinical Research Operations Manager I (CROM I) will be a senior member of assigned clinical study teams responsible for the overall operations and project management of multiple high-profile clinical studies from start up through close‑out activities. They work with all members of the IDCRC, internal and external to FHI 360, collaborating with all partners on the management, development, implementation, conduct and oversight of IDCRC multi-site clinical research studies (from approval of concepts through data analysis and manuscript submission). The CROM I must have expert knowledge 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.
The CROM I works closely with external partners on the creation and maintenance of award level governance. They closely observe, evaluate and report on study progress and site operations through study tracking, data management reports, and monitoring follow up. They may investigate and develop new methods and processes for project advancement. Ultimately, the role of the CROM is to ensure that high-quality clinical trial deliverables are conducted efficiently, within budget and in accordance with all applicable policies and procedures.
- Manages cross-functional study teams
- Serves as primary liaison for partner, sponsor and/or functional area representatives in managing clinical trial execution
- Selects, develops and evaluates clinical operations personnel to ensure efficient operations
- Coordinates the staff conducting 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
- Oversees forecasting of technical, operational, and staffing resources
- Establishes study milestones and ensures accurate tracking and reporting of study metrics
- Ensures that trial timelines, costs, and quality metrics are met
- Performs ongoing vendor management including,
- Independent negotiation of scope of work, budgets, performance management, and issue resolution
- Confirms accuracy and timeliness of vendor and site payments
- Recommends and implements innovative process ideas to impact clinical trials management
- Develops and implements study materials, which may include protocols, manuals of operation, quality management plans, clinical and safety monitoring plans and project management plans
- Leads development of training materials
- Facilitates and delivers study-specific training
- Develops project-specific staff training matrices and oversees training for study staff
- Provides general oversight of the electronic Trial Master File (eTMF) for assigned projects to ensure study document compliance for multiple clinical trials
- Identifies risks and resolves issues within the clinical project, ensuring issue escalation; may be responsible for overall project or program risk register development and maintenance
- Oversees the preparation for and participates in audits by study sponsors or other oversight bodies
- Establishes and facilitates working groups and committees
- May author or review departmental/network/company policies and procedures (e.g., standard operating procedures [SOPs] and manuals of operation [MOPs]), abstracts and manuscripts
Applied Knowledge & Skills:
- Prior experience and demonstrated success in providing cross functional project/operational management for clinical studies is required
- Ability to prioritize and multitask, proactively follow-up, effectively manage time, and assess, meet and/or adapt to changing priorities and deadlines effectively, with strong attention to detail
- Ability to lead, motivate and coordinate internal and external teams
- Ability to work efficiently in a horizontal matrix managing partners and alliances
- Ability to work independently and in a cross-cultural and geographically diverse team environment
- Ability to work with marginalized and historically excluded populations
- Effectively plans and delivers a dynamic and persuasive presentation, using effective graphics, or slides
- Ability to deliver results to the appropriate quality and timeline metrics
- Ability to establish and maintain systems and processes necessary to control and report trial status and activities
- Must be able to read, write and speak fluent English
- Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook, Teams, etc.) and experience with project management software (e.g., Microsoft Project, Monday.com, etc.) required
- Comprehensive understanding of ICH Good Clinical Practice (GCP), with knowledge of electronic data capture (EDC), electronic Trial Master File (eTMF), FDA regulations and clinical data management
Supervision Given / Received:
- Receives minimal guidance on new work
- Functions independently on projects or assignments
- Provides suggestions on business and operations decisions that affect the department
- Provides supervisory and mentoring support to other clinical research staff
- May have direct report/supervision responsibilities
- Serves as team lead to team members
- Master’s Degree or its International Equivalent in a health profession or related clinical sciences
- Requires a minimum of 10+ years of previous experience in clinical research management in pharmaceutical, biotech, CRO or non-profit organizations possessing the knowledge, skills, and abilities to perform this job
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 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.
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