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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing medical monitoring and clinical trial processes, with a strong focus on Gastroenterology and Hepatology. Proficient in medical writing, regulatory submissions, and effective communication with site investigators and regulatory bodies.
Highest-signal resume keywords
MD Or PhD In Gastroenterology & HepatologyClinical Trials ExperienceMedical WritingCTMSFDA Submission Strategies
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Medical MonitoringProtocol DevelopmentData ReviewCoding ReconciliationRegulatory Reporting
Soft Skills
Strong CommunicationAbility To Work Independently
Tools & Technologies
ExcelCTMS
Certifications & Qualifications
Licensed MD Or PhD
Industry Keywords
GastroenterologyHepatologyClinical TrialsFDA InteractionsProposal Writing
About the role
Key responsibilities & impact- Provide strategic input into current and potential clinical projects
- Support site investigators
- Manage medical monitoring and all medical aspects of clinical trials
- Provide strategic input for proposal writing and bid-defense meetings
- Support data review and medical writing for protocols and study-specific reports, including regulatory annual reports and clinical study reports
- Support FDA interactions, including IND and IDE support and related meetings
- Review and address site and CRA queries regarding inclusion/exclusion criteria
- Prepare listings of protocol deviations and adverse events for regular meetings
- Perform initial review for coding and reconcile coding based on clinical and medical team input
- Develop strategies for FDA submissions
- Develop protocols
- Prepare drafts of appropriate study plans
- Assist medical monitoring in clinical trial management
Requirements
What you’ll need- MD or PhD in Gastroenterology & Hepatology or related background
- Licensed MD or PhD
- 2 years of experience working in clinical trials as a medical monitoring associate or equivalent relevant experience
- Experience in Gastroenterology and Hepatology
- Strong communication
- Medical writing
- Ability to work independently
- Excel
- CTMS
- Willingness to work in shifts as and when needed
Benefits
Comp & perks- Variable pay
- Paid time off
- Healthcare benefits
- Retirement benefits
- Competitive salary