The role:
We are seeking an experienced and detail-oriented Clinical Systems Analyst to join our team, focusing on EDC study builds, edit check programming, user access management, lab management and adhoc programming. This role will lead the development of eCRFs and data edit check programming under tight timelines, ensuring adherence to SOPs, guidelines, and quality standards. The ideal candidate will have a strong technical background in data management, with expertise in visualization tools such as SAS, R, and Python, as well as experience in Veeva EDC.
In the role you will:
- Responsible for Study Builds in EDC and edit check programming.
- Responsible for user access management for EDC.
- Responsible for Lab management activities for Clinical studies.
- Create/oversee the development of data edit check specifications and manual data listings, as required.
- Review eCRF specifications and provide feedback on study database design.
- Lead EDC study database design review meetings in a cross-functional team environment.
- Manage clinical trial data or data management projects under aggressive timelines with high quality and in a professional manner, all while adhering to SOPs and work guidelines.
- Responsible for adhering to Data Management timelines and budgets.
- Responsible for generation of adhoc reports and listings using a variety of reporting and visualization tools.
- Review and provide feedback on study protocols and cross functional study documents e.g., Clinical Monitoring Plans, Statistical Analysis Plans, etc.
- Develop and review clinical data management functional processes, SOPs, and working instructions.
- Responsible for EDC system validation activities.
- Cooperate and assist the Quality Systems department with quality control audits on assigned Clinical study databases.
Qualifications: About you
- Bachelor or Master’s degree in Science, Healthcare, or related field
- Minimum 3-5 years of technical or programming experience within Biopharma/CRO environment.
- Oncology/Immuno-Oncology experience is preferred
- Proficient working knowledge of any of the following strongly desired: SAS, R, Python, Spotfire, Cluepoints or other Visualization Tools, Data standards (CDASH and CDISC SDTM)
- Prior study database design experience in Veeva EDC.
- Solid technical skills and fast learning ability on new technologies and applications.
- Overall understanding of ICH, GCP and other applicable regulatory guidelines as they pertain to clinical data management.
- Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a study team environment effectively works with colleagues in medical, clinical science, medical writing, clinical operation, programming, and statistics.
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