FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical research studies, ensuring compliance with GCP regulations, and effectively communicating with diverse stakeholders. Proficient in site assessment, monitoring, and maintaining data integrity throughout the clinical trial process.
Highest-signal resume keywords
Clinical Research ManagementGCP CertificationSite Assessment/MonitoringData ManagementRegulatory Compliance
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 ManagementData Integrity MonitoringDocument/File AuditsMonitoring Report CreationCTMS ProficiencyMedidata ExperienceStudy Protocol TrainingProblem ResolutionStakeholder CommunicationProject Coordination
Soft Skills
Organizational CapabilityEffective CommunicationTask PrioritizationCollaborationJudgment Exercise
Tools & Technologies
CTMSMedidataPIL Systems
Certifications & Qualifications
GCP CertificationClinical Study Monitoring Training
Industry Keywords
Clinical OperationsHuman Subjects ResearchRegulatory StatutesAudit RequirementsInstitutional Review Board
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Manage and monitor clinical research studies involving human subjects from inception to close-out according to budget and timelines
- Ensure assigned site staff are trained on study protocols and support study and data integrity
- Produce work in compliance with applicable regulatory statutes such as GCP and audit requirements
- Interface with Clinical and Medical Affairs, functional teams, internal customers, Regulatory, Legal, CRO/vendor staff, and clinical research staff
- Qualify, select, train, and monitor internal and external study investigators and study documentation
- Present technical information concerning specific projects or schedules and gain stakeholder cooperation
- Lead site management when required and communicate with business partners and key opinion leaders
- Analyze situations and data, exercise judgment within defined procedures, and resolve problems
- Communicate with sites, vendors, project teams, marketing, regulatory, and R&D
- Independently monitor and execute more complex clinical studies with guidance from a leader or manager
- Coordinate the work of specialists or coordinators without supervisory responsibility
- Create monitoring reports and follow-up documentation and ensure updates in CTMS, Medidata, and other PIL systems
Requirements
What you’ll need- BS/BA in scientific or relevant discipline
- GCP Certification of NMPA and clinical study monitoring and management training considered a priority
- Minimum of 3+ years prior experience providing administrative support in a clinical trial, data management, Institutional Review Board, or regulatory setting
- Site assessment/monitoring experience required
- Able to manage multiple tasks and priorities efficiently
- Able to prioritize and address delegated tasks in a matrix organization
- Able to work effectively with internal and external clinical research stakeholders
- Able to interpret document content accurately for filing
- Highly effective organizational capability
- Able to communicate effectively with internal colleagues and external collaborators
- Able to perform document/file audits and report deficiencies to CRAs and Managers
- Clinical Operations Competencies - Apply
Benefits
Comp & perks- A path towards your most rewarding career with high level of autonomy
- Challenging, innovative environment with great opportunities to explore
- Hybrid work flexibility: average of at least 3 days working from the office and up to 2 days from home for full-time employees
- Workspaces designed to support well-being
- Career advancement opportunities