Job Title: Clinical Team Manager (FHI Clinical)

Job Location : United States of America

Time type : Full time

About The Company

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.

Summary:

The Clinical Team Manager (CTM) will lead cross-functional teams with Project Management, Clinical Operations, and Regulatory Affairs, while understanding and managing client expectations. The Clinical Trial Manager is responsible for the day-to-day management of clinical projects, including direct communication and interaction with clinical sites, CRAs and third-party vendors. This position ensures the on-time and high-quality delivery of project-specific on-site and remote monitoring; accountability of clinical monitoring compliance, tracking of critical project tasks; strategic study enrollment support including project-specific enrollment planning and project accountability. This role will be responsible for the identification, resolution/mitigation and escalation of risks related to the monitoring of the trial.

Key Responsibilities:

• Manage the quality and clinical operations of assigned studies while remaining ICH GCP compliant
• Collaborate with the Project Manager in order to prepare, organize, and present investigator meetings.
• Deliver documents and study materials for the clinical department in a timely manner.
• Perform reviews of monitoring visit reports and confirm alignment with timeline.
• Support clinical trials as needed in order to measure performance and ensure duties are met.
• Establish and maintain the tracking tools for assigned trials, including project files both electronically and in the Trial Master File and Project Status Reports.
• Proactively identify and resolve issues and participate in process improvement initiatives.
• Develop and track study timelines, budget, and quality metrics.
• Manage study investigators, study sites, clinical monitors, clinical field specialists and third- party GCP vendors.
• Conduct regular meetings with clinical, quality, and regulatory teams to assess and mitigate emerging or potential risks.
• Collaborates with study team to ensure data milestones are met.
• Supports auditing activities to ensure that studies are conducted in accordance with sponsor protocols, GCP, industry guidelines and applicable regulations.
• Other duties as assigned.

Knowledge, skills and abilities:

• Knowledge of clinical research process, including working knowledge of all functional areas of clinical trial management.
• Strong communication skills (verbal and written) to express complex ideas.
• Excellent organizational and interpersonal skills.
• Positive attitude and ability to interact with all levels of staff.
• Must be able to manage multiple tasks and have a level of flexibility that can support group priorities across the Company.
• Ability to mentor and train clinical staff.
• Working Knowledge of Word, Excel, and Power Point.
• Working knowledge of current ICH/GCP guidelines and applicable country specific regulations.
• Willingness and ability to travel domestically and internationally as required.

Position Requirements:

• Education: Bachelor’s degree or its international equivalent.
• Preferred Job-related Experience: At least two (2) years of experience managing clinical trials within a CRO. Extensive knowledge of FDA, international regulatory regulations, GCP, ICH guidelines and regulatory requirements for clinical trial management. Prior experience in electronic data capture systems required. Strong knowledge of clinical trial processes.
• Additional Eligibility Qualifications: Strong written and verbal communication and organizational skills. Exceptional attention to detail and follow through. Strong computer literacy including proficiency in MS Project. Effective time management skills. Ability to organize tasks and set priorities in a fast-paced environment and work independently with minimal supervision. Excellent ability to collaborate across departments and disciplines. Ability to handle multiple tasks simultaneously, effectively, and efficiently with precision. Ability to adapt to changes and responsibilities and workloads. Must be professional, possess a high degree of urgency and self-motivation, and have a strong work ethic. Must possess a high degree of integrity and ability to maintain confidentiality with HIPAA guidelines, patient matters, and other confidential information.
• Preferences: Experience with Vaccination studies/trials a plus. Management of IDE trial a plus.

Physical Expectations:

• Standard office working environment.
• Majority of workday is time spent on computer work, teleconferences, reading, etc.

Travel Requirements:

• Expected travel time is 20-25% 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 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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