Your new role
• Manage / assign responsibilities for Data Managers and also serve as a member of Study Teams. Act as primary Data Management contact and contributor for projects
• Liaise with CROs, EDC vendors and other third-party vendors in a project-manager capacity in support of timelines and data-related deliverables.
• Create / monitor timelines and ensures that all deadlines are met with quality
• Participate in the review of clinical data, analysis tables, listings, figures, and patient profiles for data consistency and accuracy
• Identify and troubleshoot operational problems and barriers for studies based on metrics data, audit reports, and input from project team members and other stakeholders
• Review and provide feedback on protocols, Statistical Analysis Plans, etc.
• Develop and support creation of data management documentation, specifications and UAT requirements for database and test according to UAT Plan
• Create, review and revise data management documentation
• Ensures data management activities are conducted in accordance with GCP, GCMP, internal SOPs, and meet all regulatory requirements
• Identify project challenges and risks, and proposing appropriate and strategic solutions to issues
What you'll need to succeed
• BA or BS degree in a health-related field preferred
• +5 years of related experience in clinical data management in the Pharmaceutical, Biotechnology industry or equivalent
• Electronic data capture experience (Medidata Rave) and working knowledge of Oncology indications
• Proficient in data management activities including CRF and clinical database design, clinical data cleaning and analysis for Oncology trials
• Overall understanding of ICH, GCP, CDISC and other applicable regulatory guidelines as they pertain to data management
• Knowledge of SDTM models and experience transforming raw data into those standards
• Knowledge of Data Management and Pharmacovigilance processes in clinical trials.
• Knowledge and coding experience using MedDRA and Who Drug dictionaries
What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1225508