Medical Monitor II
Job description
About the Position
Medical Monitor II
Code: 36367
Posted: 2026-05-18
Type: Contract
Location: Princeton, NJ
Remote: No
Salary Range: $160 - $169 Per Hour
Category: Clinical Development
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
Data Review & Analysis
- 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
Regulatory & Clinical Documentation
- 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
CRO & Vendor Collaboration
- 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
Safety & Pharmacovigilance Support
- 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
Requirements
- Physician with a minimum of 6+ years of experience in drug development
- Prior experience in Psychiatry or Neurology is required
We Offer
- Competitive salary
- Health coverage
- Life insurance
- Disability insurance
- 401k benefits
About the Company
At Advanced Clinical, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Clinical is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.
Advanced Clinical complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact [email protected].
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Advanced Clinical is a global clinical development organization that provides CRO, FSP, Quality & Validation, and Strategic Resourcing services for biopharmaceutical and medical device organizations. Our mission is to deliver a better clinical experience for our clients. With global experience in over 50 countries, we are committed to improving all lives touched by clinical research. We understand the complex nature of the clinical research industry and approach each opportunity with compassion. Together, we answer the hopes of patients and healthcare professionals with industry-leading services in global life-sciences.