Manager, Clinical Trial Management – Oncology

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

📋 Description

• Oversee the quality and timely provision of site management services by designated Clinical Research Associates across various therapeutic programs and projects.

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

• Assist in ensuring proper resourcing and effective delivery strategies.

• Collaborate with Project Management, Site Management, Study Start Up, therapeutic teams, and Global Quality Assurance to facilitate clinical delivery and meet project requirements.

• Train Clinical Research Associates and Lead Clinical Research Associates through project-specific training, which includes SOPs, quality enhancement, CAPA requirements, and Clinical Monitoring Plans.

• Evaluate clinical quality and project health by monitoring site visit report compliance, source data verification, onsite activities, data query status, scope of work, and resource availability.

• Act as a primary contact for the Project Management Franchise Lead.

• Assist in proposal defense and client meetings for both new and ongoing business as necessary.

• Identify opportunities for enhancing performance and quality, including training needs identified from CAPA information.

• Manage assigned personnel, overseeing the quality of their clinical work and conducting performance appraisal reviews.

• Work collaboratively with global teams across different time zones.

⛳️ Requirements

• A four-year degree with a major in biological, physical, health, pharmacy, or a related science, along with eight years of clinical research experience as a Clinical Research Associate; or equivalent education/training and ten years of Clinical Research Associate experience.

• A minimum of two additional years of experience in managing Clinical Trial Managers.

• Capability to lead staff and facilitate effective clinical delivery.

• Extensive protocol knowledge and a thorough understanding of the biopharma industry, drug development lifecycle, and operational clinical trial delivery.

• Therapeutic knowledge is preferred.

• Strong understanding of FDA regulations, ICH Guidelines, HIPAA, clinical research principles, and standard operating procedures.

• Experience with EDC systems, including InForm and Medidata.

• Knowledge of clinical data collection and editing processes.

• Excellent strategic thinking and problem-solving abilities.

• Competence in decision-making, effective planning, organization, and maintaining attention to detail.

• Exceptional written, verbal, and interpersonal communication skills.

• Proficiency in English.

• Willingness to travel up to 30%, including some international travel.

🏝️ Benefits

• Competitive benefits package tailored to location.

• Inclusive and equitable work environment.

• Transparent compensation and pay equity practices.

• Equal employment opportunities for all.

• Opportunities for learning, growth, and influencing the future of clinical research.