Associate Director, Data Lake Operations (GCC Pharma Client)

Job description

Summary / Position Objective The Associate Director of Clinical Data Lake Operations is responsible for designing, implementing, and managing data lake solutions tailored to clinical trials and healthcare research. This role ensures efficient data ingestion, storage, processing, and retrieval to support analytics, reporting, and regulatory compliance. A key responsibility is the development and implementation of clinical data models to standardize and integrate datasets, ensuring alignment with industry standards such as CDISC (SDTM, ADaM) and compliance with global regulations like ICH-GCP and GDPR. The Associate Director oversees workflows for data collection, cleaning, transformation, and validation, ensuring the delivery of high-quality, traceable clinical data. By collaborating with IT and Global Development business teams, the role ensures the data lake infrastructure supports organizational goals, advanced analytics, and informed decision-making. Additionally, the role focuses on leveraging clinical data models to enhance integration and interoperability across diverse clinical datasets. Job Duties - **Strategy & Vision:** Implement the vision and strategy for the Clinical Data Lake, ensuring alignment with organizational objectives and adherence to Good Clinical Practice (GCP) principles. - **Roadmap Collaboration:** Collaborate with business stakeholders and systems teams to understand clinical research needs and establish a comprehensive data lake roadmap, prioritizing high-value capabilities. - **Infrastructure Design:** Oversee the design, development, and implementation of the Clinical Data Lake, ensuring seamless integration with existing systems and processes. - **Pipeline Management:** Lead efforts to build and maintain robust data pipelines from diverse sources including EDC systems, vendor labs, Biomarker data, electronic health records (EHR), and other healthcare datasets. - **Data Security & Privacy:** Ensure the security, privacy, and compliance of clinical data in accordance with regulatory standards such as GDPR, HIPAA, FDA, and ICH-GCP guidelines. - **Access Controls:** Implement robust access controls, encryption protocols, and audit trails to safeguard sensitive clinical and patient data. - **Standards Compliance:** Ensure alignment with clinical data standards such as CDISC (SDTM, ADaM) and maintain compliance with global regulatory requirements. - **Data Modeling:** Lead the design and implementation of standardized data models to harmonize and integrate data for analytics and reporting. - **Governance:** Develop and maintain metadata management practices and data lineage tracking to ensure data integrity and transparency. - **Asset Reuse:** Partner with other data lake initiatives to promote efficient operating models, domain sharing, and reuse of data assets to minimize redundancy. - **Team Leadership:** Manage matrixed teams focused on data ingestion, quality, transformation, standardization, and visualization to deliver high-value data solutions. - **Advanced Analytics:** Drive strategies for advanced data capabilities, including analytical layers and visualization tools to support clinical decision-making. - **Innovation:** Stay updated with emerging technologies, best practices, and regulatory changes in clinical data management to ensure organizational innovation. Job Requirements Experience - **12+ years** of experience in data management, data engineering, or clinical operations, with at least **5 years** in a leadership role. - Proven experience managing large-scale data lake solutions, preferably in the healthcare or clinical research domain. Skills & Technical Expertise - Strong understanding of clinical trial processes, data standards (CDISC, SDTM, ADaM), and regulatory requirements. - Deep expertise in big data technologies such as **Spark, AWS, or Google Cloud**. - High proficiency in database management (**SQL, NoSQL**) and ETL tools. - Strong knowledge of tools for collecting and managing scientific and clinical data, such as EDC and Real World Evidence (RWE) data. - Strong knowledge of data aggregation tools and capabilities to form recommended strategies for Steering Committee consideration. - Demonstrated experience integrating data from multiple disparate sources. - Excellent leadership, communication, and stakeholder management skills. Education & Certifications - **Minimum Education:** Bachelor's or Master's degree in Computer Science, Data Science, Bioinformatics, or a related field. - **Preferred Education:** Advanced degree (MBA, MS) preferred. - **Required Licenses & Certificates:** Advanced Degree Required.