Associate Director-Clinical Data Review

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 ishita.sahu@siroclinpharm.com Job Type: Full-time Pay: $55.00 - $65.00 per hour Expected hours: 40 per week Work Location: Remote Apply tot his job Apply To this Job