Job Title = Data Manager
Location: Berkeley Heights
Duration = One year from start date
Hours = 8am to 5pm (some flexibility in start/end times); 40 hrs/week
Responsibilities will include, but are not limited to:
- Perform a Quality Check (QC) of all types of EDC database discrepancies/queries generated for a study to identify and report any data trends, database issues, etc.
- Run/generate reports from EDC database for QC of queries
- Review and reference study protocols for understanding of procedures to be collected for the trial
- Review or reference data management documents such as Data Management Plan (DMP) and eCRF Completion Guidelines when applicable, to understand the established process and the guidelines for Case Report Forms during review of the database queries.
- Reference and follow the applicable SOP/WP for the process
- BS/BA degree or equivalent in a relevant scientific discipline with a minimum of five years experience as a lead data manager in a pharmaceutical/CRO setting.
- Working knowledge of EDC databases, preferably Medidata RAVE. Knowledge of J-Review or other reporting tool and basic understanding of SDTM and CDISC.
- Ability to work on multiple studies/projects and manage workload
- Strong written and oral communication skills; ability to work in a team environment with medical personnel, clinical monitors, statisticians, programmers, and medical writers
- Proficiency in regulatory guidelines, agencies, GCP
- Knowledge of FDA/ICH guidelines and industry standard practices regarding data management
Sthree US is acting as an Employment Business in relation to this vacancy.