Description
The Medical Monitor tasks include:
Provide clinical development support including Phase 2 and Phase 3 studies, with a focus on generation, review, and interpretation of clinical data, prompt and careful assessment of safety signals and preparation of clinical documents. The contractor will work closely with internal clinical development team members, clinical management, biometrics, regulatory, pharmacovigilance, and CRO partners to support execution and reporting of clinical trials and related regulatory deliverables.
Key Responsibilities:
Clinical Development & Program Support
- Provide scientific and medical input across the program, collaborating with internal team members and CRO partners
- Support review and interpretation of clinical trial safety and efficacy data to inform program decisions and regulatory documentation
- Participate in cross functional clinical development meetings and contribute to program strategy discussions as needed
Data Review and Analysis
- Review and interpret clinical trial data, including tables, listings, and figures
- Support data cleaning activities, medical data review, and issue resolution in collaboration with CROs and internal teams
- Contribute to analyses of safety and efficacy data, including post hoc and exploratory analyses as appropriate
Regulatory and Clinical Documentation
- Contribute to authoring, reviewing, and finalizing key clinical and regulatory documents for regulatory activities, 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 compound level safety documents
- Clinical sections of regulatory submissions and related briefing documents
- Draft and/or review study level narratives and support narrative review for submission readiness
Study Design and Conduct
- Contribute to development, review, and amendment of clinical trial documents, including:
- Protocols and protocol amendments
- Informed consent documents
- Statistical analysis plans (in collaboration with Biometrics)
- Clinical trial plans and other supporting documentation
- Provide clinical input into study conduct questions and protocol interpretation during trial execution
CRO and Vendor Interaction
- Serve as a clinical development medical point of contact for CROs and external vendors
- Participate in regular meetings with CRO teams to address protocol related questions, data review issues, and trial conduct topics
- Support oversight of CRO deliverables related to clinical data, reports, and submission documents
Safety and Pharmacovigilance Collaboration
- Participate in Safety Review Team meetings and routine interactions with Pharmacovigilance as needed
- Review safety data and support evaluation of emerging safety signals in collaboration with safety colleagues
- Contribute medical input to safety related documents and benefit risk assessments
- Promptly engage with site staff if/when an SAE arises to ensure prompt management and communication as per SOPs.
Additional Responsibilities
- Support preparation and review of compound wide and cross program documents as needed
- Provide ad hoc medical/clinical development support to address regulatory, internal review, or inspection readiness activities as needed
Experience Required
- Physician with at least 6 years of drug development experience
- Experience within Psychiatry or Neurology required
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
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