Technical & Operational Leadership
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Lead and manage clinical database programming activities for multiple studies of varying complexity , ensuring adherence to established processes, standards, timelines, and quality expectations.
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Design, develop, test, and maintain clinical databases including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, and custom functions .
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Provide study-level technical support and mentorship to junior team members, resolving complex technical issues and evaluating alternative solutions.
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Create, review, and approve technical specifications and develop complex programs and technical solutions for data management systems.
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Support database build activities including eCRFs, change requests, edit checks, derivations, custom functions, interface configurations, and data migrations .
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Track and manage issues within Medidata applications, working collaboratively with vendors and escalating risks as appropriate.
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Support user access management via iMedidata and Cloud Administration .
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Assist in the management and maintenance of medical coding dictionaries, including MedDRA and WHODrug .
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Resolve data anomalies and quality issues, ensuring compliance with regulatory and internal quality standards.
Process Improvement & Documentation
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Contribute to the development of departmental documentation , including training materials, SOPs, work instructions, and process guides.
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Continuously seek opportunities to improve processes, templates, and tools to enhance efficiency, scalability, and data quality.
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Maintain comprehensive supporting documentation to ensure traceability, inspection readiness, and compliance .
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Capture and communicate lessons learned, best practices, and frequently asked questions.
Vendor & Stakeholder Management
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Oversee CRO/vendor activities related to outsourced data management systems, ensuring compliance with industry best practices, quality standards, and timelines.
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Maintain regular communication with external partners, proactively addressing issues and mitigating risks.
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Collaborate closely with cross-functional teams including Clinical Operations, Biostatistics, Safety, Medical, and IT.
Strategic Contribution
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Help end users understand technical challenges and analyze current processes to ensure solutions are fit-for-purpose and aligned with study needs.
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Contribute to system selection, implementation, and enhancement initiatives.
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Support delivery across approximately 18-20 studies per year .
Qualifications Required - Bachelor s degree in computer science, Life Sciences, or a related field.
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8+ years of experience in the pharmaceutical, biotech, or CRO industry.
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6+ years of hands-on experience in clinical trial database design and management using Medidata Rave , including Custom Function programming .
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Strong experience with eCRF design , database specifications, and data validation checks.
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Experience with QC, UAT, platform testing , and development/execution of test scripts.
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Solid understanding of the Drug Development Process , SDLC , Computer System Validation , FDA regulations , ICH-GCP , and global Health Authority guidelines.
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Proven experience supporting clinical data development, validation, execution, maintenance, and documentation for regulatory submissions .
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Experience working in Agile or hybrid development environments .
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Strong verbal and written communication skills with the ability to collaborate across global, cross-functional teams.
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Demonstrated ability to prioritize and manage multiple studies and deliverables.
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Familiarity with JReview and Business Objects .
Preferred
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Knowledge of Visual Basic, SAS, or other object-oriented programming languages .
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Experience with additional Medidata modules (e.g., RTSM, CTMS, Coder, Lab Admin, TSDV ) and system integrations.
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Understanding of relational databases and data standards such as CDISC/CDASH .
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Advanced MS Office skills (Excel, PowerPoint, Word), including complex data analysis and pivot tables.
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Strong analytical, problem-solving, and critical-thinking skills.
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Experience providing training, mentoring, and subject-matter expertise to team members.
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Ability to innovate and drive transformation toward more efficient, scalable data management solutions.
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Comfortable working independently within a collaborative, fast-paced global environment.
