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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing biomarker clinical trials and IVD kit studies, ensuring compliance with ICH-GCP and FDA regulations while overseeing project management, budgeting, and risk mitigation. Proven ability to collaborate with cross-functional teams and manage CROs effectively to deliver high-quality clinical research outcomes.
Highest-signal resume keywords
Clinical Project ManagementICH-GCP ComplianceFDA Regulations KnowledgeCRO ManagementBudget Negotiation
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 Research ExperienceProtocol DevelopmentRisk ManagementData Quality AssuranceEnrollment TrackingSample Handling WorkflowsStatistical PlanningAudit-Ready Trial Master File ManagementMitigation Plan ExecutionMulti-Site Study Management
Soft Skills
Excellent Communication SkillsIndependent Work CapabilityCollaboration in Remote Teams
Tools & Technologies
CTMSEDCETMF SystemsMS Office
Certifications & Qualifications
ACRP CCRAACRP CCRCSOCRA CCRP
Industry Keywords
Biomarker StudiesIVD Clinical Performance StudiesOncology ExperienceUrology ExperienceISO 20916ISO 14155HIPAA ComplianceClinical Trial AgreementsIRB SubmissionsQuality Metrics
About the role
Key responsibilities & impact- Plan and lead operational execution of biomarker clinical trials and IVD kit clinical performance studies from protocol development through database lock and clinical study report
- Provide operational input into protocol design, sample handling workflows and statistical planning
- Contribute to and review protocols, informed consent forms, CRFs/eCRFs, monitoring plans, budgets and timelines
- Lead site feasibility, selection and qualification
- Manage clinical trial agreements, site budgets and IRB/ethics submissions
- Plan and oversee studies from a GCP perspective, including project management, risk response and site management plans
- Manage CROs and vendors, overseeing scope, deliverables, performance and invoices
- Oversee site monitoring and resolve issues and protocol deviations
- Track enrollment, milestones, budgets and risks; implement mitigation plans
- Own study budgets, forecasting, accrual tracking and change-order management
- Lead financial oversight and negotiation of CRO and vendor contracts
- Ensure data quality through data review, query resolution and database lock
- Maintain an audit-ready Trial Master File and manage deviations and CAPAs
- Establish and lead CRO governance meetings and monitor KPIs, quality metrics and contractual obligations
- Drive escalation pathways and corrective actions for CRO performance issues
- Ensure compliance with ICH-GCP, FDA regulations, ISO 20916 and company SOPs
- Support FDA interactions and submissions, including Pre-Submissions/Q-Subs, IDE, 510(k), De Novo and PMA
- Improve clinical operations SOPs and processes
- Implement risk-based monitoring strategies and quality oversight plans
- Lead risk assessments and document and execute mitigation plans
- Partner with QA on audits and inspections and lead operational readiness activities
- Serve as primary operational contact for investigators, site staff, CROs and vendors
- Partner with medical affairs, regulatory affairs and quality teams
- Provide study status updates, metrics and risk assessments to management
Requirements
What you’ll need- Bachelor’s degree in life sciences, nursing or a related field
- 6+ years of clinical research experience in the diagnostics, medical device, biotech or pharmaceutical industry
- Independent management of multi-site clinical studies
- Strong working knowledge of ICH-GCP and FDA regulations for IVD and medical device clinical studies, including 21 CFR Parts 50, 56, 809 and 812
- ISO 20916 working knowledge and competencies
- ISO 14155 working knowledge and competencies
- Familiarity with HIPAA
- Proven clinical project management skills, including planning, budgeting, risk management and delivery of multi-site studies
- Experience managing CROs and vendors, including contract and budget negotiation
- Proficiency with CTMS, EDC, eTMF systems and MS Office
- Excellent written and verbal communication skills
- Ability to work independently and collaborate effectively in a remote, international team
- Based in the United States
- Biomarker study experience preferred
- Oncology or urology experience is an advantage
- Experience with IVD kit clinical performance studies supporting FDA submissions preferred
- Clinical research certification such as ACRP CCRA/CCRC or SOCRA CCRP is a plus
Benefits
Comp & perks- Remote work arrangement
- Willingness to travel to clinical sites and meetings as needed (approximately 20–25%)