What are the responsibilities and job description for the Medical Monitor II position at Advanced Clinical?
Key Responsibilities:
Clinical Development & Program Support
- Provide medical and scientific expertise across development programs in partnership with internal teams and external CRO collaborators
- Assist with the interpretation and review of clinical safety and efficacy data to support development decisions and regulatory activities
- Participate in cross-functional clinical development discussions and contribute to strategic planning activities as appropriate
- Review and evaluate clinical trial data outputs, including tables, listings, and figures
- Support medical data review, data cleaning efforts, and resolution of data-related issues in collaboration with internal teams and CRO partners
- Contribute to safety and efficacy analyses, including exploratory and post hoc evaluations when applicable
Support the drafting, review, and finalization of clinical and regulatory documents, including but not limited to:
- Protocols
- Clinical Study Reports (CSRs)
- Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE)
- Investigator’s Brochure (IB) updates
- DSURs and other safety-related compound documents
- Clinical sections of regulatory submissions and briefing materials
- Prepare and/or review study narratives and assist with narrative quality review in support of submission readiness
- Study Design & Conduct
- Assist in the development, review, and revision of study-related documentation, including:
- Clinical protocols and amendments
- Informed consent forms
- Statistical analysis plans (in collaboration with Biometrics)
- Clinical trial execution plans and supporting materials
- Provide medical guidance regarding protocol interpretation and study conduct throughout trial execution
- Act as a medical and clinical development liaison for CROs and external vendors
- Participate in routine meetings with CRO teams to address protocol questions, data review findings, and operational study issues
- Support oversight of CRO-generated deliverables related to clinical data review, reporting, and regulatory submissions
- Participate in Safety Review Team meetings and collaborate with Pharmacovigilance colleagues as needed
- Review safety information and contribute to the assessment of emerging safety signals
- Provide medical input into safety documentation and benefit-risk evaluations
- Engage promptly with investigative sites when Serious Adverse Events (SAEs) occur to ensure timely communication and management in accordance with applicable procedures
- Additional Responsibilities
- Support the preparation and review of program-level and cross-functional clinical documents as needed
- Provide ad hoc medical and clinical development support for regulatory activities, internal reviews, and inspection readiness initiatives
- Physician with a minimum of 6 years of experience in drug development
- Prior experience in Psychiatry or Neurology is required
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Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.
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