Description
Exciting large Biotech company that focuses on oncology studies is looking to bring on a CDM II. PLEASE ONLY APPLY IF YOU HAVE IMMEDIATE HANDS ON EXPERIENCE AS A CLINICAL DATA MANAGER and have worked with various EDC systems.* Participate in the evaluation and selection of vendors, e.g. Contract Research Organizations (CROs), EDC software, for outsourced clinical data management activities.
* Develop and manage timelines for key clinical data management deliverables in coordination with the clinical data management CRO and project team.
* Review and approve key clinical data management deliverables, including: Case Report Form (CRF) design, CRF completion guidelines, database design specifications, data entry guidelines, data management plans, edit check specifications, serious adverse event reconciliation plans, medical coding and electronic data transfer agreements. Monitor vendor performance to ensure that timelines and data quality standards are met.
* Assist with the evaluation, selection, and implementation of new technologies to enhance data management processes.
* Support the implementation of CDISC standards.
* Participate in the development of clinical data management working practices and Standard Operating Procedures (SOPs).
* Ensure compliance of clinical data management processes with applicable regulations and guidelines
Job Requirements: * Bachelor's degree or equivalent with a minimum of 3-5 years experience in clinical data management across phase 1-3 clinical trials.
* Experience managing vendors and data management activities from project initiation through to database closeout.
* Working knowledge of at least one clinical database system (electronic data capture experience preferred).
* Experience with CDISC CDASH and SDTM standards.
Requires a minimum of 3-5 years of experience in clinical data management.
To find out more about Real please visit www.realstaffing.com