Description
Looking for Data Managers in the Seattle, Washington area for an exciting Oncology focused Biotech Company! Candidates considered must have had a Pharmaceutical, Biotech, or Medical Device background and have worked with multiple EDC systems.Responsibilities include:
- Acting as Lead Data Manager for assigned studies, lead and conduct Data Management Study Start-Up including the development and review of Case Report Forms, edit check specifications, eCRF completion guidelines and Data Management Plans/Data Review Strategy and the execution and documentation of User Acceptance Testing.
- Perform ongoing data review (including External Data Reconciliation and SAE Reconciliation) and discrepancy management for assigned clinical projects.
- Lead and conduct interim and final database locks for assigned clinical projects.
- Represent data management at cross-functional team meetings providing accurate study status updates and proactive communication of data management risks.
- Manage Data Management service provider for assigned outsourced studies.
- Develop and maintain data transfer agreements with External Data Vendors. Manage data transfers for assigned clinical studies.
- Participate in the evaluation of Clinical Data Management Systems including EDC and ePRO solutions.
- Participate in the development of department SOPs and standards/templates with focus on CDISC/CDASH implementation.
Requirements:
- Bachelor's degree or higher in the scientific, biological, statistical or computer science field or related discipline.
- At least 4 years of clinical trial data management experience in the pharma/biotech industry.
- Experience in the execution of a complete DM study cycle (Start-Up, Conduct, Close-Out) a plus.
- Data management experience using EDC systems such as Medidata, Medrio or iMednet with interest in database development.
- Proficiency with the Microsoft Office Suite (Excel, Word, PowerPoint, Project and Outlook).
- General knowledge of industry standards and best practices such as CDISC/CDASH data standardization.
- Ability to manage competing priorities and anticipate and escalate issues in a timely manner.
- Proven track record of on-time and high quality Data Management deliverables.
- Excellent communication and interpersonal skills.
To find out more about Real please visit www.realstaffing.com