This position will function as the subject matter expert for data acquisition, archive and interchange of data for clinical research studies and the clinical reporting environment. They will lead the development of standards for data collection and data transmission; and collaborate with cross-functional teams to develop new therapeutic area standards and supporting data review tools. The Clinical Programmer will define best practices for data acquisition and develop Nektar standards adhering to CDISC conventions and regulatory guidelines. This position will maintain a global library of standard forms, edit checks, reports and data listings used to facilitate the clinical development process. This position contributes to and supports the company's research and development efforts to create high value therapeutics to address unmet medical needs.
Works on extremely complex problems in which analysis of situations for data requires an evaluation of intangible variables. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Provide leadership and direct activities in the areas of Database Design/Programming, Systems Development/Support and Training. Function as EDC and CDISC expert providing guidance and best practices to clinical teams. Advise and direct the teams about standards in CRF development, validation, and reporting. Implement and maintain standards for data collection, acquisition, archival, and submission of data for clinical research studies in accordance with appropriate regulatory guidance (CDISC). Oversee EDC development and testing environments. Perform functional auditing and vendor qualifications. Develop and maintain Nektar global standards and project specific specifications. Define programming and reporting standards, conventions and rules. Define regulatory-compliant data exchange standards with both external business partners (CRO, central labs, IXRS, eCOA, etc.) and internal partners (Biostatistics, Clinical Operations, etc.) Oversee activities related to external vendors supporting multiple trials to ensure consistency in data collection, transmittal and reporting. Implement and maintain a regulatory-compliant process for acquisition, archive, and interchange of clinical study data. Co-ordinate with CRO's on data collection instruments, reporting tools, and system requirements. Implement a tracking mechanism for process and clinical system-related issues.
A minimum of a BS in Computer Science, Information Technology, or other related area. Typically requires a minimum 8 years hands on relevant career experience in the pharmaceutical or biotechnology industry. Excellent verbal, written and computer skills across multiple applications including proficiency in programming languages and tools (J-Review, SpotFire, SAS, Java, C++, etc.), relational databases (SQL Server, Oracle, MySQL, PL/SQL, etc.), and Microsoft Office (Word, Excel, Outlook, PowerPoint, etc.) are required. Experience developing Clinical databases (e.g. Medrio, Medidata RAVE, Oracle Inform, etc.). Knowledge of external data sources (e.g. central labs, IXRS, eCOA). Demonstrated ability to work on complex technical problems providing innovative solutions. Demonstrated problem solving abilities and strong organizational skills. Demonstrated proficiency with ICH, GCDMP, CDISC and GCP is required. Demonstrated self-starter with the ability to mentor and handle multiple tasks to meet deadlines while delivering high quality work in a dynamic work environment. Must possess excellent project management and communication skills and have demonstrated ability to develop processes and training. Previous people management experience is preferred. Solid understanding of clinical drug development processes is preferred.