Role Summary
Axtria is seeking a dynamic leader for our Clinical Solutions business to spearhead Clinical Information Management programs for pharmaceutical R&D clients. This role will drive the design and implementation of clinical data workflows, data standardization, data quality frameworks, and analytics-ready data provisioning. Acting as a Subject Matter Expert (SME), you will guide project teams in building customized clinical data pipelines, regulatory-compliant solutions, and scalable architectures that meet client-specific requirements. The position offers an opportunity to innovate in clinical data management, strengthen client relationships, and shape Axtria's growth in a rapidly evolving market.
Core Responsibilities
- Strategic Leadership: Define and execute the vision for Clinical Information Management within Axtria's Clinical Solutions COE. Supervise Associate Directors and junior team members, ensuring delivery excellence and capability development.
- Client Engagement & Growth: Serve as the primary technical consultant for pharma clients, translating complex business needs into scalable technical solutions. Build and nurture senior client relationships, leveraging industry networks to expand Axtria's footprint.
- Solution Architecture & Delivery: Oversee design and implementation of clinical data pipelines across EDC, CDMS, CTMS, SCE, LIMS, RIMS, and related systems. Ensure compliance with GxP regulations, CDISC/SDTM, HL7/FHIR, and other industry standards. Drive data governance, QA, audit readiness, and submission workflows for clinical trials, registries, and late-phase studies.
- Innovation & Thought Leadership: Champion emerging technologies and best practices in clinical data management and analytics. Represent Axtria as a thought leader in industry forums and client discussions.
- Team Development: Mentor and inspire a high-performing team of SMEs and delivery leads. Foster a collaborative, results-driven culture across onshore/offshore teams.
- Create new capabilities, propose and lead proof of concepts (PoCs), and develop GTM collateral to support sales and business development initiatives.
- Maintain high CSAT and NPS scores to ensure customer satisfaction and long-term client relationships.
Technical Skills
- Cloud Platforms: AWS, Azure, GCP for hosting and managing clinical data solutions.
- Data Engineering: Expertise in ETL processes, data pipeline design, and orchestration tools (e.g., Apache Airflow).
- Big Data Technologies: Familiarity with Spark, Hadoop for large-scale clinical data processing.
- Database Management: Proficiency in SQL and NoSQL databases for structured and unstructured data storage.
- API Integration: Experience in integrating clinical systems and third-party applications using RESTful APIs.
- Data Security & Compliance: Strong understanding of HIPAA, GDPR, and GxP compliance for clinical data handling.
- DevOps/CI-CD: Knowledge of containerization (Docker, Kubernetes) and continuous integration/deployment pipelines.
- AI/ML Familiarity: Awareness of machine learning techniques for clinical data analytics and predictive modeling.
Qualifications
- Education: Bachelor's or Master's degree in Life Sciences, Computer Science, Data Management, or related field. Advanced degree preferred.
- Experience: 15+ years in clinical data management/information management, with at least 5 years in leadership roles. Proven track record in designing and implementing clinical data workflows, regulatory compliance frameworks, and analytics-ready solutions. Expertise in clinical trial systems (EDC, CDMS, CTMS, LIMS, RIMS), data standards (CDISC, HL7), and GxP environments. Strong client-facing experience and ability to lead large-scale programs.
- Skills: Strategic thinking, solution architecture, and delivery oversight. Excellent communication and stakeholder management skills. Ability to lead cross-functional teams and manage offshore delivery models.
