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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 monitoring lab services, ensuring compliance with GCP and ICH regulations, and managing project documentation. Proficient in coordinating with investigators and vendors to support clinical trials in medical device and drug development.
Highest-signal resume keywords
Clinical Research ExperienceGCP KnowledgeProject Management CertificationDigital Pathology ExperienceOrganizational 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 Trial ManagementRegulatory ComplianceData ManagementSpecimen ManagementQuery ResolutionPerformance MonitoringStudy DocumentationLaboratory Kit CoordinationProcess MappingMultitasking
Soft Skills
Attention to DetailCollaborationCommunicationOrganizational Skills
Tools & Technologies
PathAI AISight CT Platform
Certifications & Qualifications
Project Management Certification
Industry Keywords
Clinical TrialsMedical Device DevelopmentDrug DevelopmentICH GuidelinesTitle 21 CFR
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Monitor clinical trial lab services and engage with clinical investigator sites
- Support the primary Clinical Trial Manager (CTM)
- Apply knowledge of GCP, ICH, regulatory requirements, and Title 21 of the Code of Federal Regulations
- Oversee timely closure of queries issued to investigator sites and designated parties
- Identify trends and provide feedback on Investigator and PathAI BioPharma Laboratory performance
- Monitor investigators, laboratory performance, study requirements, queries, pending results, and testing turnaround times
- Collaborate with data management to resolve data discrepancies
- Organize and track storage specimens, including receipt, retrieval, and shipping
- Coordinate with external vendors and sponsors to deliver laboratory kits and test results
- Perform routine study duties, including site lists, laboratory manuals, laboratory kit orders, specimen management reports, case assignments on the PathAI AISight CT Platform, and pending lab analysis
- Support CTM administrative tasks, including action item tracking, meeting minutes, and process mapping
- Provide backup CTM support, including client communication and study management
- Collaborate with functional areas, vendors, Laboratory, Engineering, and support services
- Coordinate site-level project information and escalate discrepancies
- Assist with meeting and training materials
- Support study start-up deliverables, milestones, project documentation, and close-out procedures
- Perform other administrative or process-related duties as needed
Requirements
What you’ll need- 3+ years of clinical research experience in medical device and/or drug development clinical trials
- BS or BA in a relevant scientific discipline
- Good organizational skills
- Attention to detail
- Ability to multitask
- Experience in digital pathology, radiology or other imaging technology-based clinical trials is highly preferred
- Project Management Certification is a plus
Benefits
Comp & perks- Remote work option
- Relocation benefits are not available for this position