Summary of the Position:

The Clinical Trial Manager (CTM) will work collaboratively across cross-functional teams with Project Management, Clinical Operations, Data Management, Medical Monitoring, Pharmacovigilance, and Regulatory Affairs while understanding and managing client expectations. The Clinical Trial Manager is responsible for the day-to-day management of clinical aspects of projects, including 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 clinical team accountability. This role will be responsible for the identification, resolution/mitigation, and escalation of risks related to site management and monitoring of the trial.

Essential Functions:

1. Manage the quality and clinical operations of assigned studies while remaining ICH GCP compliant.

2. Collaborate with the Project Manager to prepare, organize, and present investigator meetings.

4. 3. Deliver documents and study materials for the clinical department promptly.

5. Primary responsibility for the generation of the Clinical Monitoring Plan.

6. Establish and maintain tracking tools for assigned trials and ensure maintenance of relevant sections of the Trial Master File and Project Status Reports.

7. Perform reviews of monitoring visit reports and confirm alignment with the timeline.

8. Establish and maintain the tracking tools for assigned trials, including project files both electronically and in the Trial Master File and Project Status Reports.

9. Proactively identify and resolve issues and participate in process improvement initiatives.

10. Develop and track timelines, budget, quality, and performance metrics for clinical operational activities. Manage study investigators, study sites, clinical monitors, clinical field specialists, and any assigned vendors.

11. Conduct regular meetings with the Clinical Research Associates, and actively participate in team meetings with functional leads to assess and mitigate emerging or potential risks.

12. Collaborates with the study team to ensure data milestones are met. Supports auditing activities to ensure that studies are conducted by sponsor protocols, GCP, industry guidelines, and applicable regulations.

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 PowerPoint.
• 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, preferably in nursing or life science. In lieu of a degree, an equivalent combination of education and relevant work experience is required.
• Preferred Job-related Experience: At least two (2) years of experience managing clinical trials within a CRO. Five (5) or more years of monitoring experience required or relevant experience in lieu. Extensive knowledge of relevant international regulations and guidelines, ICH GCP, and other relevant GCP guidelines for clinical trial management. Prior experience in electronic data capture (EDC) and electronic clinical trial management (CTMS) systems is 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 Office Suite. Effective time management skills. Ability to organize tasks 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 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 and other relevant country-specific confidentiality/protection of privacy and personal information guidelines, patient matters, and other confidential information.
• Preferences: Experience with Vaccination and device studies/trials is advantageous.

Physical Expectations:

• Typical office environment.
• Ability to sit or stand for extended periods.
• Ability to lift or move 5-15 lbs. or 2.26 – 6.8kg.

Travel Requirements:

• Valid Driver’s license and passport must be always maintained.
• 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. and its subsidiary and affiliate companies provide 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.

Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.

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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