Sr. Clinical Programmer (EDC Specialist)
455 Mission Bay Blvd. (South) San Francisco, CA 94158
Our client is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates which are designed to improve the benefits of drugs for patients.
- The position is an integral part of Clinical Data Management (CDM) responsible for the development, implementation and maintenance of the systems and applications supporting Drug Development across multiple therapeutic areas.
- This position will function as the subject matter expert for EDC, data acquisition, archive and interchange of data for clinical research studies and the clinical reporting environment.
- They will support the development of EDC 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 develop and 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.
- Experience implementing Clinical databases (e.g. Medidata RAVE, Oracle Inform, etc.) and developing supporting procedures.
- Knowledge of external data sources (e.g. central labs, IXRS, eCOA).
- 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.
- 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.