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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, regulatory compliance, and team leadership, ensuring successful execution of clinical studies while fostering staff development and operational efficiency.
Highest-signal resume keywords
Clinical Research ManagementPeople Management ExperienceRegulatory ComplianceMicrosoft Office Suite ProficiencyClinical Trial Research Processes
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 ResearchTrial Master File ManagementData InterpretationProcess ImprovementSite ActivationSite MaintenanceCTMS/Tracker UpdatesAudit ReadinessStudy Site ComplianceProject Management
Soft Skills
Strong Communication SkillsInterpersonal SkillsOrganizational SkillsAnalytical SkillsPresentation Skills
Certifications & Qualifications
SoCRA CertificationACRP Certification
Industry Keywords
Clinical Site OperationsRegulatory Audit ExperienceClinical Protocol ComplianceTalent DevelopmentCore Deliverables
About the role
Key responsibilities & impact- Supervise a team of In-house Clinical Research Associates within Clinical Site Operations
- Support US, Canada, and LATAM clinical site operations
- Assist with hiring, training, developing, and retaining qualified staff
- Ensure teams achieve core deliverables for assigned clinical studies
- Manage site invitation, site activation, site maintenance, amendments, reactivation, progress reports, and CTMS/tracker updates
- Ensure regulatory and clinical protocol compliance across assigned clinical projects
- Complete site-level Trial Master Files and maintain site audit readiness
- Prepare for and support site audits
- Manage study site compliance escalations, site closure, and final report distribution
- Support team career and personal development, talent profiles, goals, and objectives
- Collaborate with Site Management, Operations, and GCO colleagues to achieve regional and national goals
- Provide process training to internal and external clinical personnel
- Communicate with employees, customers, contractors, and vendors
- Apply clinical research and regulatory expertise to improve processes and efficiencies
- Lead small projects and process improvement efforts
- Plan, organize, monitor performance, and report status
- Provide input to SOPs and Departmental Work Instructions
- Serve as Business Unit Champion and main contact for the Site ICRA team
- Drive activation and review timelines and risks to support study execution
- Engage in professional associations and continuing education
- Support ad-hoc projects and Core Team activities 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 function 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 exchange straightforward information, ask questions, and check for understanding
- 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: Excellent understanding of clinical research and familiarity with clinical trial research processes
- Preferred: Related clinical or corporate research experience, or relevant clinical/hospital experience
- Preferred: SoCRA, ACRP, or similar research professional certification
- Preferred: Regulatory audit experience
- Organization, coordination of multiple tasks, accuracy, and attention to detail
Benefits
Comp & perks- Career development with an international company
- Free medical coverage through the Health Investment Plan (HIP) PPO medical plan, subject to qualification in the next calendar year
- Retirement savings plan with a high employer contribution
- Tuition reimbursement
- Freedom 2 Save student debt program
- FreeU education benefit toward a bachelor’s degree
- Diverse career opportunities
- Up to 20% travel opportunity