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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 and medical oversight, with a strong focus on oncology and hematology. Capable of managing complex clinical trials while ensuring compliance with GCP and regulatory standards.
Highest-signal resume keywords
Medical DegreeOncology ExpertiseBoard Certified OncologyClinical Research ExperienceGCP 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 OversightProtocol DevelopmentSafety Data MonitoringData AnalysisMedical CodingRegulatory SubmissionsAdverse Event ReviewInvestigator SelectionDrug Development SupportLiterature Searches
Soft Skills
Excellent Communication SkillsInterpersonal SkillsTeam CollaborationOrganizational SkillsIndependent Work
Tools & Technologies
ECRFsClinical Study ReportsSOPsQuality Improvement Practices
Certifications & Qualifications
Board Certified OncologyBoard Eligible Oncology
Industry Keywords
Biopharmaceutical IndustryClinical ResearchOncologyHematologyFDA InteractionMedical MonitoringDrug DevelopmentClinical Data Interpretation
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Provide medical and scientific support to clinical research programs, study teams, and investigators
- Provide medical oversight for clinical trials as Medical Monitor on behalf of sponsor companies
- Serve as primary contact for sponsor medical teams and front-line medical resource for project teams
- Provide 24/7 support for protocol inclusion/exclusion criteria, protocol clarifications, compliance issues, and alert-lab review
- Review clinical research proposals, preclinical and clinical data, protocols, training materials, informed consent, Investigator Drug Brochures, eCRFs, analysis plans, clinical study reports, regulatory submissions, and adverse events
- Ensure medical activities comply with GCP and operate efficiently
- Develop and maintain medical/scientific consultant networks
- Supervise and manage Medical Director activities
- Support drug development programs, study design, protocol development, investigator selection, recruitment, retention, and investigator meetings
- Develop medical monitoring plans and provide on-call protocol and site support
- Monitor safety data, review SAE reports and narratives, track safety queries, and address safety issues
- Review IND/SUSAR safety reports, Investigator Brochures, annual IND reports, and treatment unblinding procedures
- Interact with FDA officials regarding safety and study-related issues as requested
- Review eCRFs, data analysis plans, safety fields, data reconciliation, medical coding, data tables, listings, figures, and clinical study reports
- Support DSMB and adjudication committee activities
- Support business development through proposals, marketing presentations, sales presentations, and feasibility discussions
- Conduct literature searches and support training, clinical-data interpretation, report writing, SOPs, working practices, and quality-improvement efforts
- Perform other related duties assigned by the Chief Medical Officer
Requirements
What you’ll need- Medical Degree from an accredited and internationally recognized medical school with a curriculum relevant to general medical education
- 10 years of experience required, including medical practice, academia, clinical research, or drug development
- 3–5 years of biopharmaceutical industry experience preferred
- Oncology / Hematology expertise
- Board Certified / Board Eligible: Oncology (Required)
- Preferably Urologist / Surgical Oncology
- Ability to work in partnership with multidisciplinary colleagues
- Ability to translate concepts into practical approaches and promote consensus
- Ability to work independently with minimal supervision and effectively within a team and matrix environment
- Ability to organize and work efficiently on several projects with shifting priorities
- Excellent oral and written communication and interpersonal skills
Benefits
Comp & perks- Full-time employment
- 12 months fixed-term contract
- Diversity, inclusion, and belonging culture
- Opportunity to work with talented employees worldwide
- Team and multidisciplinary collaboration