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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial management, including oversight of site operations, compliance with GCP and regulatory requirements, and effective collaboration with cross-functional teams. Proficient in managing clinical trial processes, training initiatives, and driving operational improvements within the pharmaceutical or biotechnology industry.
Highest-signal resume keywords
Clinical Trial ManagementGCP ComplianceOn-Site Clinical MonitoringCTMS ProficiencyRegulatory Documentation Management
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Trial ManagementOn-Site Clinical MonitoringRegulatory Documentation ManagementGCP ComplianceICH-GCP KnowledgeFDA Regulations KnowledgeEMA Regulations KnowledgeOperational ImprovementData Quality Metrics ReviewPatient Recruitment Strategies
Soft Skills
Organizational SkillsPresentation SkillsStakeholder ManagementTraining and DevelopmentCross-Functional Collaboration
Tools & Technologies
CTMSETMFMicrosoft Office
Industry Keywords
Clinical TrialsPharmaceutical IndustryBiotechnology IndustryOncology TrialsRegulatory Submissions
About the role
Key responsibilities & impact- Oversee site management, monitoring oversight, and clinical trial operations activities
- Ensure compliance with GCP, regulatory requirements, and company SOPs
- Partner with Clinical Operations leadership to support clinical trial execution and monitoring activities
- Lead site feasibility, selection, initiation, and greenlight activities
- Develop and maintain study-specific operational plans, training materials, and monitoring documentation
- Oversee site engagement, regulatory submissions, and monitoring activities
- Review trial progress, patient recruitment, and data quality metrics, and implement actions to support study objectives
- Provide guidance and oversight to CRAs, including trip report review and training support
- Manage protocol and GCP deviations
- Contribute to continuous improvement of clinical operations processes and procedures
- Collaborate with cross-functional teams and clinical sites
- Travel domestically and internationally, up to 50%
Requirements
What you’ll need- Bachelor’s degree in life sciences, nursing, or a related field
- 2+ years of experience in on-site clinical monitoring
- 2+ years of Clinical Trial Manager experience within the pharmaceutical or biotechnology industry
- Strong knowledge of ICH-GCP, FDA, EMA, and applicable clinical trial regulations
- Demonstrated experience managing clinical trial sites, monitoring activities, and regulatory documentation
- Proficiency with clinical trial systems and tools, including CTMS, eTMF, and Microsoft Office
- Experience in oncology clinical trials or related therapeutic areas preferred
- Advanced ability to manage complex clinical operations processes and drive operational improvements preferred
- Experience leading training initiatives for CRAs and clinical trial sites preferred
- Demonstrated ability to drive quality, efficiency, and milestone achievement in fast-paced clinical environments preferred
- Experience contributing to process harmonization, innovation, and continuous improvement initiatives preferred
- Strong presentation, organizational, and cross-functional stakeholder management skills preferred
- Must be authorized to work in the United States without current or future sponsorship
- Successful completion of background check, reference checks, and pre-employment drug screening required; additional screenings may apply for certain roles
Benefits
Comp & perks- Competitive rates for Health, Dental, and Vision Insurance
- 4 weeks of vacation, granted up front each year and prorated for first and last year of employment
- 12 company paid holidays
- 7 days of sick time
- 100% employer-paid life insurance up to 1x annual salary, up to one hundred thousand dollars
- 100% employer-paid short- and long-term disability coverage
- 401(k) with immediate eligibility and company match
- Partially paid parental leave for eligible employees
- Additional voluntary employee-paid benefits and services, including accident, hospital indemnity, and critical illness insurance, as well as identity theft protection and pet insurance
- Fully remote work arrangement
