Clinical Research Manager

JOB SUMMARY

The Clinical Research Manager oversees the day-to-day operations and execution of clinical trials at a specific site. They manage all aspects of clinical trial site operations, ensuring adherence to protocols, regulatory guidelines, and performance metrics. This role includes developing strategies to optimize site performance, supervising and mentoring staff, managing resources, and coordinating with investigators and central operations to integrate research with patient care. The manager also ensures site readiness, supports audits, oversees compliance, and directly participates in research activities such as participant recruitment and data collection, if needed. Strong leadership, organizational, and regulatory expertise, along with effective communication and problem-solving skills, are essential for success in this role.

RESPONSIBILITIES

• Develop and implement strategies to achieve site-level performance metrics.
• Drive research growth by addressing barriers, ensuring compliance, and maintaining quality standards with a sense of urgency.
• Manage site staff, including timekeeping, performance evaluations, and performance improvement plans; hire, train, and develop new team members with central support.
• Hold staff accountable for meeting quality, compliance, and performance standards while providing coaching and mentorship.
• Ensure site staff readiness for research activities, including meeting First Patient Visit (FPV) timelines.
• Delegate responsibilities, set clear expectations, and provide regular feedback to team members. Support onboarding and career development opportunities for new and existing staff.
• Foster relationships with investigators and build partnerships with the local medical director.
• Facilitate integration between clinical research and clinical care and act as the primary contact for the Partner Site.
• Advocate for site staff and Partner Site needs to support strong study execution and performance.
• Prepare for and guide staff during FDA audits and sponsor-initiated quality assurance audits in coordination with Central Operations.
• Oversee the availability of supplies and equipment necessary for research studies.
• Coordinate pre-study, site qualification, study initiation, monitoring visits, and study close-out activities. Support the collection and review of essential study documents and reports.
• Provide back-up support, if needed:
• Conduct or oversee key research activities such as participant screening, recruitment, scheduling, protocol adherence, data collection, and query resolution.
• Perform clinical functions as needed, including phlebotomy, obtaining vitals, and educating participants and families. Assist in evaluating participants for inclusion/exclusion criteria.
• Collect, process, and ship laboratory specimens when required.
• Ensure compliance with company, clinic, and sponsor policies, standard operating procedures (SOPs), and applicable regulatory requirements.
• Perform additional duties as assigned.

QUALIFICATIONS

• Minimum 3 years of experience coordinating clinical trials, including relevant activities listed above.
• A Master’s degree or previous management experience may substitute for one year of trial coordination experience.
• Certified Clinical Research Coordinator (CCRC) credential required.
• Bachelor’s degree in Life Sciences or a related discipline, preferred.
• Strong knowledge of FDA regulations and ICH guidelines.
• Preferred experience in training and mentoring clinical research professionals.
• Excellent interpersonal skills with strong attention to detail and a positive attitude.
• Demonstrated ability to work effectively across all staff levels to coordinate and execute study activities.
• Proficiency in Microsoft Office Suite (Outlook, Word, Excel, PowerPoint, SharePoint) and clinical trial master filing systems.
• Strong organizational and prioritization skills for managing multiple concurrent studies.
• Proficiency in regulatory and central IRB submission processes.
• Excellent verbal and written communication skills.
• Ability to work independently and in a matrix team environment.
• Ability to be on-site, travel for clinic activities, and attend investigator meetings or vendor audits as required.