This is a professional individual contributor role that provides oversight and accountability for more than one low to moderate complexity trial or one high complexity trial. May be a member of more than one project of low to moderate complexity or member of one project of high complexity.
This position requires In-depth knowledge of the protocol. In-depth knowledge of current clinical drug development processes is needed. In-depth knowledge of applicable international guidelines regarding data management of clinical trials is required. This position needs to understand relevant system/technical knowledge. In-depth knowledge of current industry standards (i.e., CDISC, SDTM, CDASH, etc.) is required. Knowledge of technology platforms, confidentiality for data exchange, and project management and techniques is required.
Plans and tracks content, format, quality, and timing of data management deliverables, including, but not limited to, CRF, data review plan, QC plan, oversight plan, database release plan, final datasets, submission plan and archival. Ensures deliverables are on time.
Takes a leadership role with the assigned clinical working group(s) to ensure that IDS and TA trial needs and deliverables are met.
Identifies and communicates lessons learned, best practices and frequently asked questions at the trial level.
Identifies and participates in process, system, and tool improvement initiatives within IDS.
Presents and trains at investigator and monitor meetings.
PRA is an EEO/AA employer and is committed to providing opportunities to minorities, women, veterans and individuals with disabilities.