Manager, Clinical Operations Site Management – Franchise Lead, CNS

🔥 44 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $112k - $222k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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Worldwide Clinical Trials

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

Worldwide Clinical Trials is a global contract research organization (CRO) that provides comprehensive clinical trial services. They specialize in supporting studies across diverse therapeutic areas such as oncology, cardiology, and rare diseases. With over 30 years of experience, Worldwide Clinical Trials emphasizes personalized support and customized solutions throughout the entire lifecycle of drug development. Their services include clinical monitoring, data management, patient recruitment, and regulatory consulting, ensuring precision and tailored attention for each clinical trial.

📋 Description

• Provide therapeutic and operational expertise throughout the program and project delivery lifecycle • Ensure that projects within the franchise are properly resourced • Collaborate with the therapeutic team to create effective delivery strategies and solutions for franchise projects and programs • Act as the main contact person for the Project Management Franchise Lead • Present at proposal defense and client meetings as needed to support new or ongoing business • Ensure CRAs are trained on project specifics • Ensure Lead CRAs (LCRAs) are trained to support the clinical scope of work, including standard operating procedure (SOP) review, quality issue (QI)/corrective and preventive action (CAPA) understanding, and the Clinical Monitoring Plan • Coordinate and collaborate with Worldwide Clinical Trials Global Quality Assurance to provide training opportunities identified through CAPA information • Manage the quality of the assigned staff’s clinical work • Coordinate efforts between Project Management, Site Management, and Study Start‑Up • Establish regular communication to include quality metrics (such as site visit report compliance, source data verification metrics, and on‑site metrics) and overall project “health” metrics (such as data query status, adherence to the scope of work, and resource status) • Conduct performance appraisals for direct reports

🎯 Requirements

• Four‑year college curriculum with a major concentration in biological, physical, health, pharmacy, or other related sciences, and 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 • Two or more years of management experience • Extensive CNS experience required • Strong protocol knowledge; therapeutic knowledge preferred • Comprehensive global knowledge, awareness, and practical understanding of the biopharma industry, drug development lifecycle, and operational clinical trial delivery • Innovative and strategic thinker • Superior oral and written communication skills • Strong planning and organizational skills • Strong interpersonal skills • Experienced problem‑solving and decision‑making skills • Strong attention to detail • Understanding of clinical research principles and processes, including data collection and editing skills • Ability to navigate Electronic Data Capture (EDC) software such as InForm and Medidata • Strong 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 depending on location • Pay equity and transparency