Associate Director, Clinical Data Reporting (GCC Pharma Client )

Job description

Summary / Position Objective The Associate Director of Clinical Data Management Reporting will provide leadership and operational oversight for clinical and external data reporting across Clinical Development Unit (CDU) programs. This role will drive the development, standardization, and timely, high-quality execution of clinical data programming deliverables, external data reconciliation workflows, and reporting outputs, ensuring alignment with study data review plans (DRPs), program milestones, and regulatory requirements. Responsibilities include delivering critical data review listings, exception reports, external data reconciliation outputs, and operational data visualizations that support clinical trial quality, compliance, and risk management. The Associate Director will lead and mentor internal teams, coordinate with external vendors, and collaborate with cross-functional partners to ensure study needs are met and data integrity maintained. The role requires strong expertise in clinical data programming, external data integration and reconciliation, industry standards, and data management systems essential for driving consistency, operational excellence, and continuous improvement. Job Duties - **Operational Oversight:** Lead and provide program-level operational oversight for the planning, coordination, and delivery of high-quality clinical data management programming outputs across clinical development programs. - **Deliverable Management:** Oversee the development and delivery of clinical programming and visualization outputs such as participant-level data review listings, exception reports, external data reconciliation reports, and operational metricsensuring alignment with study data review plans and program needs. - **Standards & Efficiency:** Contribute to the development and maintenance of clinical data reporting standards, templates, macros, and assist in implementing scalable programming approaches to enhance quality and efficiency. - **Subject Matter Expertise:** Provide subject matter expertise in clinical data programming, data extraction, transformation, and visualization, and relevant technologies to enhance and advance internal reporting capabilities. - **Cross-Functional Collaboration:** Partner with cross-functional teams to align priorities, coordinate deliverables, support data review activities, and ensure efficient execution of programming activities. - **Quality & Compliance:** Support quality-by-design principles by ensuring programming and reporting deliverables adhere to established standards, regulatory requirements, risk-based approaches, and inspection-ready expectations. - **Process Improvement:** Contribute to continuous improvement initiatives aimed at modernizing clinical data reporting workflows through standardization, process refinement, and automation capabilities. - **Risk Management:** Proactively identify and manage risks related to data quality, integrity, or delivery timelines, to maintain compliance and delivery commitments. - **Performance Metrics:** Monitor key performance indicators (KPIs) to assess adherence to programming standards, identify process gaps, and recommend enhancements to reporting capabilities. - **Documentation & SOPs:** Contribute to the development and maintenance of SOPs, Work Instructions, and training materials related to clinical data management programming and reporting. - **Inspection Readiness:** Support inspection readiness and regulatory compliance by maintaining accurate documentation, contributing to audit preparation, and health authority inquiries. - **Technology Evaluation:** Lead the evaluation and operational implementation of new reporting tools and technologies, ensuring alignment with the departmental goals to enhance data insights, visualizations, automation, or analytical capabilities. - **Leadership & Mentorship:** Provide leadership, coaching, and day-to-day guidance to clinical data management reporting staff, support skill development, performance growth, and operational excellence. Mentor programming team members, promoting knowledge sharing, technical development, and consistent application of best practices. Job Requirements Educational Qualifications - **Required:** Bachelors degree + 10 years of relevant experience. - **Preferred:** Advanced degree desirable. Experience and Skills - **Industry Experience:** 10+ years of clinical data management experience in a pharmaceutical or biotech setting. - **Leadership:** 5+ years of people management, leadership, and mentoring experience. - **Programming & Visualization:** Demonstrated ability to oversee the development, validation, and delivery of clinical data management programming and visualization outputs to cross-functional groups. - **Oversight Solutions:** Strong background in creating interactive reporting solutions, KPIs, and metrics to support clinical trial oversight. - **Data Transformation:** Hands-on experience in transforming raw clinical data and external data into clean, analysis-ready datasets through processing, validation, and reconciliation activities. - **Problem Solving:** Ability to function as a subject matter expert (SME) in clinical data management programming and reporting for solving complex issues. - **Data Types:** Proficiency in managing and reconciling clinical eCRF and external data types (e.g., PK, ADA, Biomarker, Imaging, ECG). - **Industry Standards:** Working knowledge of clinical data management principles, technologies (data extraction, transformation, integration), and regulations (21 CFR Part 11, ICH-GCP, CDISC standards). - **Technical Toolkit:** Proficiency with industry-standard reporting and visualization tools such as SAS, R, JReview, Spotfire, Tableau, Power BI, or R Shiny. - **Communication:** Strong interpersonal, verbal, and written communication skills. - **Flexibility & Travel:** Ability to adjust in a fast-paced environment and travel up to 25%.