Job Description
Job Title: Associate Director, Clinical Science – Clinical Data Review
Location: USA (Remote)
Job Description:
Associate Director, Clinical Science – Clinical Data Review to support clinical data review activities across the lifecycle of studies within the GI2 Therapeutic Area Unit. This role partners with medical monitors and cross-functional stakeholders to ensure data quality, compliance, and inspection readiness.
Key Responsibilities:
- Data Review Oversight:
- Develop, manage, and track clinical data listings.
- Collaborate with medical monitors for timely and thorough data review.
- Analyze and report data review metrics.
- Study Documentation & TMF Support:
- Contribute to study documentation from start-up to close-out.
- Ensure Trial Master File (TMF) completeness and inspection readiness.
- Support study archival in compliance with regulatory requirements.
- Operational Excellence:
- Perform User Acceptance Testing (UAT) and support clinical tool implementations.
- Contribute to operational strategies and process improvements.
- Cross-functional Collaboration:
- Liaise with Clinical Operations, Data Management, Pharmacovigilance, and Statistics.
- Promote consistency of clinical data review operations across the GI2 TAU.
- Compliance & Inspection Readiness:
- Ensure adherence to GxP, SOPs, and regulatory requirements.
- Identify and mitigate risks to inspection readiness.
- Qualifications / Skills:
- 8+ years of experience in clinical research, including data review, medical monitoring support, or clinical operations.
- Strong knowledge of clinical development processes, data review methodologies, and regulatory compliance.
- Experience in global matrix organizations, preferably FSP or CRO model.
- Proven project management skills managing clinical and data management activities for large programs.
- Experience across all phases of development in one or more therapeutic areas preferred.
- Proficiency with clinical data systems: Veeva, RShiny, Elluminate, Medidata, JReview.
- Solid understanding of clinical trial documents: protocols, SAPs, CRFs, study reports.
- Strategic knowledge of FDA and ICH regulations and industry standards.
- Excellent communication, organizational, and leadership skills.
Interested candidates can send their Resume on [email protected]
Job Type: Full-time
Pay: $55.00 - $65.00 per hour
Expected hours: 40 per week
Work Location: Remote
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