Sr Clinical Programmer
$160k - $185kInternational Executive Service Corps
The Sr. Clinical Programmer is an integral member of the CDM team and is responsible for developing, implementing, and maintaining the systems and applications that support CDM and Development Operations across multiple therapeutic areas. Senior Clinical Programmer Position Summary Serving as the subject matter expert for data acquisition, archival, interchange, and reporting of clinical research data, this role leads the development of standards for data collection and transmission and collaborates with cross-functional teams to define therapeutic area standards and data review tools. The Senior Clinical Programmer defines best practices for data acquisition, develops company standards aligned with CDISC conventions and regulatory guidance, and maintains a global library of standard forms, edit checks, reports, and data listings. This role directly contributes to the company’s research and development efforts to deliver high-value therapeutics that address unmet medical needs.
- Address highly complex technical problems requiring analysis of nuanced data and intangible variables; exercise independent judgment in developing methods, techniques, and evaluation criteria.
- Provide leadership and direction for database design and programming, systems development and support, and training activities.
- Serve as the EDC and CDISC subject matter expert, providing guidance and best practices to clinical study teams.
- Advise on standards for CRF development, validation, and reporting; implement and maintain standards for data collection, acquisition, archival, and submission in compliance with CDISC and applicable regulatory guidance.
- Oversee EDC development and testing environments; perform functional audits and vendor qualifications.
- Develop and maintain global standards and project-specific specifications, including programming and reporting conventions and rules.
- Define regulatory-compliant data exchange standards with external partners (CROs, central labs, IXRS/IRT, eCOA) and internal teams (Biostatistics, Clinical Operations).
- Oversee vendor activities across multiple trials to ensure consistency in data collection, transmission, and reporting.
- Implement and maintain regulatory-compliant processes for data acquisition, archival, and interchange.
- Coordinate with CROs on data collection instruments and reporting tools and establish tracking mechanisms for process- and system-related issues.
- Mentor team members and contribute to the continuous improvement of CDM processes, tools, and training.
- Working knowledge of external data sources (e.g., central labs, IXRS/IRT, eCOA).
- Proficiency in programming and reporting tools such as J-Review, Spotfire, SAS, Java, and C.
- Strong experience with relational databases (SQL Server, Oracle, MySQL, PL/SQL).
- Proficiency in Microsoft Office (Word, Excel, Outlook, PowerPoint).
- Demonstrated proficiency with ICH, GCDMP, CDISC, and GCP guidelines is required.
- Demonstrated ability to solve complex technical problems with innovative solutions.
- Strong organizational, project management, and communication skills.
- Demonstrated ability to develop processes and training materials.
- Self-starter with the ability to mentor others and manage multiple priorities while delivering high-quality work in a dynamic environment.
- Solid understanding of clinical drug development processes preferred.
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