Associate Manager, Clinical Operations – FSP

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee and develop a clinical operations team comprising Clinical Research Associates.

• Contribute to resource planning and manage assignments effectively.

• Ensure monitoring oversight to maintain quality standards and compliance with relevant directive documents and ICH/GCP guidelines.

• Conduct comprehensive performance evaluations and manage direct reports, including PMD, IDP, Line of Sight Goals, and performance feedback mechanisms.

• Address and resolve any performance-related issues.

• Hold Clinical Operations personnel accountable for quality, compliance, project timelines, contractual obligations, source data verification, monitoring visit schedules, trip report quality, and timely deliverables.

• Participate in resource management activities for direct reports.

• Oversee expense management, approve expense reports, and ensure adherence to the Travel Policy.

• Assess performance metrics for assigned team members.

• Identify training needs and assist with regional training and development initiatives.

• Communicate strategies, policies, and procedures to leadership teams.

• Build relationships with management teams to effectively manage staff in a matrix environment.

• Conduct, report, and follow up on Quality Control Visits.

• Maintain relationships with both internal and external clients to foster additional business opportunities.

• Supervise site-level evaluations, initiation processes, patient recruitment and retention, monitoring, data collection, and closure of clinical trial sites.

• Manage a team of 5–10 direct reports.

• Execute other assigned responsibilities.

⛳️ Requirements

• Bachelor's or college degree in life sciences or a certification in a relevant allied health profession from an accredited institution, or equivalent relevant experience in place of educational qualifications.

• At least two years of supervisory experience in a healthcare or clinical research setting, along with six years of relevant clinical research experience in a pharmaceutical company/CRO as an alternative to the educational requirements.

• Minimum of four years of pertinent clinical research experience within a pharmaceutical company/CRO.

• Proficiency in on-site monitoring activities, including pre-study assessments, initiation, routine monitoring, and closeout visits.

• Comprehensive understanding of the drug development process.

• In-depth knowledge of applicable SOPs, ICH, and GCP guidelines.

• Experience with Phase I monitoring is preferred.

• Some experience in a Line Manager or Project Manager role is preferred.

• Ability to lead by example and motivate team members to find solutions.

• Strong interpersonal skills.

• Capability to effectively participate as a team member on project teams.

• Ability to manage multiple competing priorities efficiently.

• Exceptional planning and organizational skills.

• Excellent oral, written, and presentation communication skills.

• Willingness to travel globally up to 25–50% of the time, which will include overnight stays.

🏝️ Benefits

• Flexible remote work arrangement.

• Home-based work environment.

• Coverage for travel expenses and overnight stays as required by the role.