Clinical Trial Manager I – Oncology

Jobtailor; North Carolina; On-site; USD 120,000 - 180,000; Full time

Job summary

Jobtailor is seeking a Clinical Trial Manager to own the delivery and operational oversight of clinical research trials. You will collaborate with project managers and functional leads to ensure successful start-up, activation, and execution within budget and contract parameters.

The role involves site identification, regulatory submissions, and maintaining data integrity and compliance on a global scale. Flexible leadership in remote and cross-functional teams, with a focus on patient safety

Qualifications

• University/college degree (life science preferred) or certification in related allied health profession.
• Two to three years of clinical research experience in pharma, CRO, or healthcare setting.
• Fluent in English, written and verbal.

Responsibilities

• Own clinical delivery and operational oversight of clinical research trials.
• Collaborate with project managers and functional leads to deliver activities within budget and contract.
• Oversee start-up and clinical responsibilities from site identification through database lock.
• Identify and address project, financial, quality, and operational risks.
• Forecast revenue and oversee contracted scope and scope modifications.
• Lead regulatory and ethics committee submissions, approvals, and tracking.
• Ensure inspection-readiness through quality oversight of TMF, monitoring reports, and deviations.

Skills

Leadership

Communication

Planning

Organizational skills

Problem-solving

Independent work

Education

Bachelor's degree (life science)

Tools

EDC

CTMS

ETMF

Veeva Vault

Medidata

Job description

• Own clinical delivery and operational oversight of clinical research trials
• Collaborate with project managers and functional leads to deliver clinical and start-up activities within budget and contract
• Oversee start-up and clinical responsibilities from site identification through database lock
• Manage project scope, timelines, milestones, budget, quality, compliance, and country-specific commitments
• Identify and address project, financial, quality, and operational risks
• Forecast revenue and oversee contracted scope and scope modifications
• Track client-specific Key Project Indicators and resource projections
• Develop and implement site activation and recruitment strategy
• Lead site identification and selection
• Oversee informed consent form development and translations
• Oversee essential document creation and collection, including insurance
• Oversee development, negotiation, and execution of Clinical Trial Agreements and site budgets
• Lead regulatory and ethics committee submissions, approvals, and tracking
• Ensure clinical and ancillary supplies, import/export logistics, and destruction processes are in place
• Support subject recruitment and retention, patient safety, vendor performance, and monitoring visit strategy
• Plan monitoring activities to ensure data integrity, patient safety, and endpoint protection
• Ensure inspection-readiness through quality oversight of TMF, monitoring reports, protocol deviations, and issue management
• Oversee and approve site payments and payment reconciliation
• Foster client and cross-functional team communication in a global, multicultural environment
• Lead client-facing calls and communicate project status and operational control
• Support new business through pre-award preparation
• Provide feedback on team members to line managers
• Perform other assigned duties

Requirements

• University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution
• Relevant and equivalent experience may be considered in lieu of educational requirements
• Fluent in English, written and verbal
• Two to three years of relevant clinical research experience in pharmaceutical, CRO, or health care setting will be considered
• 1 year of CTM or Lead CRA experience
• CRA experience (onsite monitoring)
• Comprehensive knowledge of GCP, ICH, and regulatory guidelines
• Proficiency in Microsoft Office
• Familiarity with EDC, CTMS, eTMF, and vendor platforms such as Veeva Vault and Medidata
• Effective leadership in remote and global environment
• Strong communication, planning, and organizational abilities
• Proven team motivational skills
• Proficiency in balancing concurrent tasks within time-sensitive environments
• Financial awareness and use of tracking systems/tools
• Demonstrated independent problem-solving and risk management mindset
• Demonstrated professional client interaction and presentation skills
• Ability to work independently and collaboratively
• Oncology experience
• PMP certification or equivalent preferred

Core Competencies

Demonstrates expertise in clinical trial management, including oversight of clinical research trials, regulatory compliance, and project management. Proficient in stakeholder communication and risk management within a global, multicultural environment.

Highest-signal resume keywords

• Clinical Trial Management
• GCP, ICH, And Regulatory Guidelines
• Oncology Experience
• PMP Certification
• Microsoft Office Proficiency

Hard Skills

• Clinical Research Experience
• Site Activation And Recruitment Strategy
• Project Scope Management
• Budget Oversight
• Risk Management
• Data Integrity Monitoring
• Informed Consent Form Development
• Clinical Trial Agreements Negotiation
• Client-Specific Key Project Indicators Tracking
• Financial Awareness

Soft Skills

• Effective Leadership
• Strong Communication Abilities
• Planning And Organizational Skills
• Team Motivational Skills
• Independent Problem-Solving

Certifications & Qualifications

• PMP Certification

Industry Keywords

• Pharmaceutical
• CRO
• Health Care
• Oncology
• Clinical Research

Tools & Technologies

• EDC
• CTMS
• ETMF
• Veeva Vault
• Medidata