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Worldwide Clinical Trials

Manager, Clinical Trial Management – Oncology

Worldwide Clinical Trials

. Lead the quality and timely delivery of site management services provided by assigned Clinical Research Associates across therapeutic programs and projects .

Posted 11/9/2026full-timeRemote • North Carolina • United StatesSeniorLead💰 $112,000 - $222,000 per yearWebsite

Core Competencies

Role fit
Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive experience in clinical research management, including leading Clinical Research Associates and ensuring compliance with FDA regulations and ICH Guidelines. Possesses strong therapeutic knowledge and operational expertise in the biopharma industry and clinical trial delivery.

Highest-signal resume keywords
Clinical Research ManagementFDA Regulations KnowledgeClinical Trial DeliveryEDC Systems NavigationTherapeutic Knowledge

ATS Keywords

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Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills
Clinical Research ExperienceProtocol KnowledgeClinical Monitoring PlansSource Data VerificationData Query StatusQuality ImprovementCAPA RequirementsClinical Data CollectionProject-Specific TrainingOperational Clinical Trial Delivery
Soft Skills
Strategic ThinkingProblem-SolvingDecision-MakingOrganizational SkillsInterpersonal Communication
Tools & Technologies
InFormMedidata
Industry Keywords
Biopharma IndustryDrug Development LifecycleClinical Research PrinciplesSOPsHIPAA

About the role

Key responsibilities & impact
  • Lead the quality and timely delivery of site management services provided by assigned Clinical Research Associates across therapeutic programs and projects
  • Provide therapeutic and operational expertise throughout the program and project delivery lifecycle
  • Help ensure appropriate resourcing and effective delivery strategies
  • Partner with Project Management, Site Management, Study Start Up, therapeutic teams, and Global Quality Assurance to coordinate clinical delivery and address project needs
  • Develop Clinical Research Associates and Lead Clinical Research Associates through project-specific training, including SOPs, quality improvement and CAPA requirements, and Clinical Monitoring Plans
  • Monitor clinical quality and project health through site visit report compliance, source data verification, onsite activity, data query status, scope of work, and resource status
  • Serve as a key contact for the Project Management Franchise Lead
  • Support proposal defense and client meetings for new and ongoing business as needed
  • Identify opportunities to strengthen performance and quality, including training needs arising from CAPA information
  • Manage assigned staff, including the quality of their clinical work and appraisal performance reviews
  • Collaborate with global teams across multiple time zones

Requirements

What you’ll need
  • A four-year college curriculum with a major concentration in biological, physical, health, pharmacy, or another related science, plus eight years of clinical research experience as a Clinical Research Associate; or equivalent education/training plus ten years of Clinical Research Associate experience
  • At least two additional years of experience managing Clinical Trial Managers
  • Ability to lead staff and support effective clinical delivery
  • Broad protocol knowledge and comprehensive understanding of the biopharma industry, drug development lifecycle, and operational clinical trial delivery
  • Therapeutic knowledge is desired
  • Strong knowledge of FDA regulations, ICH Guidelines, HIPAA, clinical research principles, and standard operating procedures
  • Experience navigating EDC systems, including InForm and Medidata
  • Understanding of clinical data collection and editing
  • Strong strategic thinking and problem-solving skills
  • Ability to make decisions, plan effectively, stay organized, and maintain attention to detail
  • Excellent written, verbal, and interpersonal communication skills
  • Proficiency in English
  • Ability to travel up to 30%, including some international travel

Benefits

Comp & perks
  • Competitive benefits package depending on location
  • Inclusive and equitable workplace
  • Transparent compensation and pay equity
  • Equal employment opportunities
  • Opportunities to learn, grow, and shape the future of clinical research