Manager, Clinical Operations Site Management (Franchise Lead) - CNS - U.S. (Remote)
Job Overview
Location
Research Triangle Park, North Carolina
Job Type
Full-time
Category
Product Management
Date Posted
June 25, 2026
Full Job Description
đź“‹ Description
- • Provide therapeutic and operational expertise throughout the clinical program and project delivery lifecycle for CNS franchise projects.
- • Ensure proper resourcing of projects within the CNS franchise to meet timeline and quality objectives.
- • Collaborate with the therapeutic team to develop and implement effective delivery strategies for CNS clinical programs.
- • Serve as the primary point of contact for the Project Management Franchise Lead on CNS-related initiatives.
- • Represent the Site Management team in proposal defenses and client meetings to support new or ongoing CNS business.
- • Train Clinical Research Associates (CRAs) on specific protocol requirements, study procedures, and project-specific expectations.
- • Train Lead CRAs (LCRAs) on clinical scope of work, including SOP review, quality issue (QI)/corrective and preventive action (CAPA) processes, and the Clinical Monitoring Plan.
- • Coordinate with Global Quality Assurance to deliver training based on CAPA findings and quality improvement needs.
- • Manage and monitor the quality of clinical work performed by direct-report CRAs and LCRAs.
- • Coordinate cross-functional efforts between Project Management, Site Management, and Study Start-Up teams to ensure seamless execution.
- • Establish and maintain regular communication channels to report on quality metrics (e.g., site visit report compliance, source data verification rates, on-site metrics) and project health indicators (e.g., data query status, scope adherence, resource availability).
- • Conduct formal performance appraisals for direct reports in Site Management.
- • Apply comprehensive knowledge of the biopharma industry, drug development lifecycle, and operational clinical trial delivery.
- • Demonstrate strong understanding of U.S. FDA regulations, ICH guidelines, and HIPAA compliance in clinical operations.
- • Navigate Electronic Data Capture (EDC) systems including InForm and Medidata for clinical data management.
- • Interpret and apply standard operating procedures (SOPs) to ensure compliance across all site management activities.
- • Maintain detailed attention to clinical data accuracy, protocol adherence, and regulatory documentation.
- • Travel to clinical trial sites as required to support monitoring, training, and quality assurance activities.
- • Maintain a valid passport to support international travel as needed for global clinical operations.
🎯 Requirements
- • Four-year college degree in biological, physical, health, pharmacy, or related science with eight years of clinical research experience as a CRA, OR equivalent education/training with ten years of CRA experience
- • Two or more years of management experience
- • Extensive CNS therapeutic area experience required
- • Proficiency in EDC systems such as InForm and Medidata
- • Deep knowledge of FDA regulations, ICH guidelines, and HIPAA
- • Valid passport and willingness to travel
🏖️ Benefits
- • Annual salary range of $112,000.00 - $222,000.00
- • Competitive benefits package (location-dependent)
- • Transparent compensation and pay equity practices
- • Opportunities for professional growth based on competency and independent performance
Skills & Technologies
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About Worldwide Holdings Corporation
Worldwide Holdings Corporation is a diversified global enterprise engaged in the development, manufacturing, and marketing of a wide range of products and services. The company operates across various sectors, including technology, consumer goods, and industrial solutions, with a strong focus on innovation and sustainability. Worldwide Holdings Corporation is committed to delivering high-quality products and exceptional customer service, aiming to foster long-term relationships with its clients and stakeholders. The company's strategic vision involves expanding its global reach, investing in research and development, and adapting to evolving market demands to maintain a competitive edge in the international marketplace. Their mission is to create value through responsible business practices and a dedication to excellence.
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