Associate Manager, Clinical Operations – FSP

🔥 0 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $120k - $130k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🏥 Clinical Operations

👻 Ghost score 0%

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Manage and develop a clinical operations team consisting of Clinical Research Associates • Contribute to and oversee resource planning and assignments • Provide monitoring oversight to ensure activities meet quality requirements and applicable directive documents and ICH/GCP standards • Conduct detailed performance reviews and manage direct reports, including PMD, IDP, Line of Sight Goals, and “Shoves and Tugs” • Manage and resolve performance issues • Hold Clinical Operations staff accountable for quality, compliance, project plans, contract obligations, source data verification, monitoring visit cycles, trip report quality, and timely deliverables • Engage in resource management activities for direct reports • Manage expenses, approve expense reports, and ensure compliance with the Travel Policy • Measure performance indicators for assigned staff • Escalate training needs and assist with regional training and development • Communicate management strategies, policies, and procedures with leadership teams • Develop relationships with management teams to manage staff in a matrix environment • Conduct, report, and follow up on Quality Control Visits • Maintain relationships with internal and external clients to support additional business opportunities • Oversee site-level evaluation, initiation, patient recruitment and retention, monitoring, data collection, and clinical trial site closeout • Manage 5–10 direct reports • Perform other assigned duties

🎯 Requirements

• University/college degree in life sciences or certification in a related allied health profession from an appropriately accredited institution, or equivalent relevant experience in lieu of educational requirements • Minimum of two years supervisory experience in a health care or clinical research setting and six years relevant clinical research experience in a pharmaceutical company/CRO as an alternative to the required education background • Minimum of four years relevant clinical research experience in a pharmaceutical company/CRO • Proficiency with on-site monitoring activities, including pre-study, initiation, routine monitoring, and closeout visits • Thorough knowledge of the drug development process • Thorough knowledge of relevant SOPs, ICH, and GCP guidelines • Phase I monitoring experience preferred • Some experience as a Line Manager or Project Manager preferred • Ability to lead by example and encourage team members to seek solutions • Proven interpersonal skills • Ability to participate successfully as a member of a project team • Ability to manage multiple competing priorities • Excellent planning and organizational skills • Excellent oral, written, and presentation skills • Ability to travel globally up to 25–50% of the time, with all travel requiring overnight stays

🏖️ Benefits

• Remote work arrangement • Home-based work environment • Travel expenses and overnight travel as required by the role