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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading and executing Phase 1–3 clinical studies, with a strong focus on medical monitoring and scientific input for clinical trial protocols. Proven ability to mentor clinical scientists and manage complex studies in the pharmaceutical industry, particularly in Immunology.
Highest-signal resume keywords
Clinical Study LeadershipMedical Monitoring ExperienceImmunology ExpertiseClinical Development CollaborationExcellent Communication 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 DesignProtocol DevelopmentEndpoint DevelopmentSAE Report ReviewData MonitoringEDC ManagementCRF ActivitiesProtocol ClarificationClinical Research ExperiencePharmaceutical Drug Development
Soft Skills
MentoringStakeholder CommunicationTeam CollaborationProblem SolvingTime Management
Tools & Technologies
ExcelPowerPointClinical Trial Management SystemsData Review PlatformsCentral Lab Reporting Tools
Industry Keywords
Clinical ScientistPhase 1–3 StudiesIRB InteractionGovernance Committee ReviewClinical Development
About the role
Key responsibilities & impact- Lead/support Phase 1–3 clinical studies
- Be accountable for clinical/scientific execution of protocols
- Serve as clinical point of contact for scientific issues and questions for internal and external stakeholders, including IRBs and sites
- Act as scientific lead on Clinical Trial Teams
- Design trials and develop endpoints in collaboration with Clinical Development
- Collaborate with medical writing on trial-results communications for investigators
- Lead Medical Monitoring activities, including development of the Medical Monitoring Plan, SAE report review, monitoring data issues, and central lab reports
- Set up/support SAC, DMC, and adjudication committees
- Provide scientific input to study management for EDC, DRP, and CRF activities
- Collaborate on protocols and amendments, participate in governance committee review, author protocol clarification letters, and reconcile/review protocol deviations for the CSR
- Mentor other Clinical Scientists
Requirements
What you’ll need- Degree in Life Sciences or significant experience in clinical development (>14 years)
- BS/BA with 7+ years clinical research experience
- MS/PhD with 5+ years clinical research experience
- Minimum 2 years pharmaceutical and clinical drug development experience in a Clinical Scientist role as a lead required
- Proven ability to effectively manage multiple complex studies
- Medical monitoring experience required
- TA-specific experience in Immunology
- Excellent Excel and PowerPoint skills required
- Excellent written and oral communication skills
- Ability to sit for extended periods and operate a vehicle safely
- Ability to access and use a variety of computer software
- Light to moderate lifting and carrying up to 15–20 lbs
- Regular and consistent attendance
- Varied hours may be required
Benefits
Comp & perks- Frequent travel to clients/site locations with occasional domestic and international travel
- EEO & accommodations support
