This position requires a sound working knowledge of clinical data management processes and database systems within a multi-disciplinary team environment.
Performs clinical data management functions in support of clinical studies.
Functions to include some or all, but not limited to: data review, protocol review, case report form (CRF) design and creation, CRF review, data entry, database validation, query generation, and validation of study results.
Assist in review and approval of vendor data management documentation, such as Data Management Plans and Data Quality Review Plans.
Participates in overseeing the data management work being performed by external vendors or contract research organizations (CROs).
Assists in training new employees, including temporary data management personnel.
Supervises and monitors team member performance to ensure the timely and accurate fulfillment
of assigned duties and tasks.
Assists with review, creation and/or updating of departmental documentation including but not limited to SOPs and training guidelines.
Coordinates with clinical study personnel to provide timely feedback on data issues for resolution by investigational sites. Jointly with clinical study personnel, develops and prioritizes appropriate timelines for the completion of databases required for submission, report writing, and/or presentation purposes.
Interacts with external laboratories in coordination with clinical study personnel to ensure that appropriate laboratory evaluations are being collected in accordance with protocol requirements and consistent with cGCP and/or approved SOPs.
Carries out direct supervisory responsibilities in accordance with the department-set goals. Responsibilities include interviewing and onboarding; employee training and development; planning, assigning, and directing work; appraising performance; rewarding and disciplining; corrective action and complaint resolution.
Bachelor’s degree in life science/biomedical/medical science with a working knowledge of the clinical/scientific terminology and methods common to the biopharmaceutical setting.
Minimum of at least 7 years of relevant experience working in a clinical research environment within biotech/pharmaceutical/CRO or healthcare setting preferred, with basic understanding of the clinical development and data management processes; or equivalent combination of education and experience.
Must have a good understanding of CRF and clinical database structures, and data management processes including CRF review, data analysis, data validation, data quality, and query generation and resolution and other key technologies (e.g., CTMS, IVRS/IWRS)
Demonstrated ability and experience overseeing external vendors
Knowledge of MS Excel, WORD, ACCESS, and PowerPoint is essential.
Individual must have good analytical, communication and personal skills, be well organized, and a good team player.
Knowledge of MedDRA coding, CDISC standard, or SAS would be a plus but not mandatory.