Manager, Clinical Trial Managers - CNS - U.S. (Remote)

About the role

The Manager, Clinical Operations Site Management (Franchise Lead) is responsible for providing on-time and quality delivery of site management services from assigned Clinical Trial Managers (CTMs) within assigned therapeutic area(s) and program(s).

Responsibilities

• 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

Broad 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

Qualifications

• 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
• Equivalent education and training with ten years of clinical research experience as a clinical research associate
• Two or more years of line management experience
• Extensive CNS experience required
• Experienced in being a direct point-of-contact for Sponsors
• Responsibility for metrics and troubleshooting
• Extensive budgetary responsibilities required
• Travel required
• Passport required

Skills

None specified in the job posting.

Benefits

Not specified in the job posting.

Pay

$112,000.00 - $222,000.00 annually

Schedule

Not specified in the job posting.