
Manager, Clinical Trial Managers – CNS
Posted Jul 18

Posted Jul 18
This is a fully remote position, open to applicants in California.
• Deliver therapeutic and operational expertise throughout the lifecycle of program and project delivery.
• Ensure appropriate 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 at proposal defenses and client meetings as necessary to support new or ongoing business initiatives.
• Ensure that Clinical Research Associates (CRAs) are trained on project-specific details.
• Ensure Lead Clinical Research Associates (LCRAs) are equipped to support the clinical scope of work, including reviewing standard operating procedures (SOPs), understanding quality issues (QIs) and corrective and preventive actions (CAPAs), as well as the Clinical Monitoring Plan.
• Coordinate and collaborate with Worldwide Clinical Trials Global Quality Assurance to create training opportunities identified through CAPA insights.
• Oversee the quality of the clinical work performed by assigned staff.
• Facilitate collaboration among Project Management, Site Management, and Study Start-Up teams.
• Establish regular communication channels that encompass quality metrics (such as compliance with site visit reports, source data verification metrics, and on-site metrics) and overall project “health” metrics (including data query status, adherence to the scope of work, and resource status).
• Conduct performance evaluations for direct reports.
• A four-year college degree with a major in biological, physical, health, pharmacy, or other related sciences, along 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.
• A minimum of two years of line management experience.
• Significant experience in Central Nervous System (CNS) research is required.
• Proven experience as a direct point-of-contact for sponsors.
• Accountability for metrics and troubleshooting activities.
• Extensive budget management experience is required.
• Willingness to travel is necessary.
• A valid passport is required.
• A competitive benefits package tailored to location.
• Commitment to pay equity and transparency.
ŌURA
Thermo Fisher Scientific
ALLEN SPOLDEN
Clinical Outcomes Solutions
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