Job Title: Associate Director - Clinical Data Reporting
Experience Level: 12+yrs
Location: Hyderabad
Preferred Industry: Pharmaceuticals & Life Sciences
Department: Data Management
Job Requirements
Knowledge, Skills & Experience
- Professional Experience: 12+ years of clinical data management, clinical data operations, reporting, or analytics experience within a pharmaceutical, biotech, or clinical research organization.
- Leadership Experience: 5+ years of direct people management, leadership, and mentoring experience.
- Program Delivery: Demonstrated ability to oversee the development, validation, and delivery of clinical data management programming and visualization outputs to clean cross-functional groups across clinical development programs.
- Data Visualization & Metrics: Strong background in creating interactive reporting solutions, KPIs, and metrics to support clinical trial oversight using industry-standard tools (e.g., SAS, JReview, Spotfire, Tableau, Power BI, or R Shiny).
- Data Processing & Reconciliation: Hands-on experience transforming raw clinical data and complex external data types (such as PK, ADA, Biomarker, Imaging, ECG, and others) into analysis-ready datasets through processing, validation, and reconciliation activities.
- Subject Matter Expertise: Demonstrated ability to function as a clinical data management programming and reporting SME to solve complex issues and guide internal teams and external vendors toward successful outcomes.
- Technical & Regulatory Standards: Working knowledge of clinical data management principles, data extraction, transformation, integration, and programming techniques. Deep understanding of regulations and industry standards including 21 CFR Part 11, ICH-GCP, and CDISC standards.
- Soft Skills: Strong interpersonal, verbal, and written communication skills with the ability to adjust and collaborate effectively within a fast-paced, cross-functional environment.
- Travel Requirements: Position may require up to 25% travel.
Educational Requirements
- Minimum Degree: Bachelor's degree required (Advanced degree desirable).
