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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research management, including oversight of clinical site operations, regulatory compliance, and team leadership. Proficient in developing staff, improving processes, and ensuring successful study execution.
Highest-signal resume keywords
Clinical Research ManagementPeople Management ExperienceRegulatory ComplianceTrial Master File ManagementStrong Communication Skills
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 ResearchData InterpretationProcess ImprovementPerformance MonitoringSOP Development
Soft Skills
Interpersonal SkillsAnalytical SkillsOrganizational SkillsPresentation SkillsTeam Collaboration
Tools & Technologies
Microsoft Office SuiteClinical Applications
Certifications & Qualifications
Research Professional CertificationSoCRA CertificationACRP Certification
Industry Keywords
Clinical Trial ProcessesSite ManagementAudit ReadinessStudy ComplianceTalent Development
About the role
Key responsibilities & impact- Supervise a team of personnel within Clinical Site Operations supporting the US, Canada, and LATAM
- Assist management with hiring, training, developing, and retaining qualified staff
- Oversee In-house Clinical Research Associates
- Ensure teams achieve core deliverables for assigned clinical studies
- Manage site invitation, activation, maintenance, amendment/re-activation, progress reporting, and closure activities
- Ensure regulatory and clinical protocol compliance
- Complete site-level Trial Master Files and maintain site audit readiness
- Prepare for and support site audits
- Manage study site compliance escalations
- Support career and personal development, talent profiles, goals, and objectives
- Collaborate with Site Management and Operations and GCO on regional and national goals
- Provide training on functional processes to internal and external clinical personnel
- Improve clinical research processes and efficiencies
- Lead small projects and process improvement efforts
- Monitor performance and report status
- Provide input to SOPs and Departmental Work Instructions
- Serve as a Business Unit Champion and point of contact for the Site ICRA team
- Review timelines and risk and develop solutions to drive study success
- Participate in professional associations, continuing education, Core Team activities, and ad-hoc projects as assigned
Requirements
What you’ll need- Two-year degree or equivalent experience
- At least 5 years of people management experience
- Experience with clinical research and/or the specific functions being overseen
- Strong written and verbal communication, interpersonal, presentation, analytical, and organizational skills
- Ability to interpret basic clinical data and meet deadlines
- Proficiency in Microsoft Office Suite and relevant clinical applications
- Ability to work independently when necessary
- Ability to learn new systems for trial master file management and regulatory submissions
- Preferred: 4-year college degree
- Preferred: 5 or more years of clinical research experience
- Preferred: 2 or more years of people management or experience in the specific function overseen
- Preferred: certification as a Research Professional by SoCRA, ACRP, or similar professional society
- Preferred: regulatory audit experience
- Strong understanding of clinical research and clinical trial processes
- Up to 20% travel may be required
Benefits
Comp & perks- Career development with an international company
- Free medical coverage eligibility through the Health Investment Plan (HIP) PPO medical plan in the next calendar year
- Excellent retirement savings plan with a high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit toward a bachelor’s degree
- Opportunities to grow and learn
- Employee diversity and inclusion programs