Manager, Clinical Operations Site Management – Franchise Lead, CNS

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

📋 Description

• Deliver therapeutic and operational expertise throughout the lifecycle of program and project delivery.

• Ensure adequate resourcing for projects within the franchise.

• Collaborate with the therapeutic team to develop effective delivery strategies and solutions for franchise projects and programs.

• Serve as the primary contact for the Project Management Franchise Lead.

• Present during proposal defenses and client meetings as necessary to support new or ongoing business initiatives.

• Guarantee that Clinical Research Associates (CRAs) receive training on project specifics.

• Ensure that Lead CRAs (LCRAs) are adequately trained to support the clinical scope of work, which includes reviewing standard operating procedures (SOPs), understanding quality issues (QI)/corrective and preventive actions (CAPA), and the Clinical Monitoring Plan.

• Coordinate with Worldwide Clinical Trials Global Quality Assurance to identify and provide training opportunities based on CAPA findings.

• Oversee the quality of clinical work performed by assigned staff.

• Facilitate collaboration among Project Management, Site Management, and Study Start-Up teams.

• Establish regular communication to include quality metrics (such as compliance with site visit reports, source data verification metrics, and on-site metrics) as well as overall project "health" metrics (such as data query status, adherence to the scope of work, and resource status).

• Conduct performance evaluations for direct reports.

⛳️ Requirements

• A four-year college degree with a major in biological, physical, health, pharmacy, or other related sciences, coupled with eight years of clinical research experience as a clinical research associate, OR equivalent education and training with ten years of clinical research experience as a clinical research associate.

• At least two years of management experience.

• Extensive experience in Central Nervous System (CNS) required.

• Strong understanding of protocols; therapeutic knowledge is preferred.

• Comprehensive global knowledge and practical understanding of the biopharma industry, including the drug development lifecycle and operational clinical trial delivery.

• Innovative and strategic thinker.

• Excellent oral and written communication abilities.

• Strong planning and organizational skills.

• Exceptional interpersonal skills.

• Proficient in problem-solving and decision-making.

• Keen attention to detail.

• Familiarity with clinical research principles and processes, including data collection and editing skills.

• Competence in navigating Electronic Data Capture (EDC) software such as InForm and Medidata.

• Solid knowledge of U.S. Food and Drug Administration (FDA) regulations, International Council for Harmonisation (ICH) guidelines, and the Health Insurance Portability and Accountability Act (HIPAA).

• Understanding of standard operating procedures.

🏝️ Benefits

• Competitive benefits package based on location.

• Commitment to pay equity and transparency.