The Senior Clinical Data Manager coordinates and completes data management activities to ensure accuracy and consistency of clinical databases for subsequent analysis and reporting.
To perform this job successfully an individual must be able to perform each essential function satisfactorily.
• Coordinate and complete data management activities to meet project timelines and communicate status to respective team members.
• Perform coding review for adverse events, medical history and concomitant medications and coordinate medical monitor review and approval of medical coding with the clinical study manager.
• Responsible for data management activities, database cleaning and lock activities including developing data management plans, supervising database development and reviewing and processing clinical trial data to ensure completeness, accuracy and consistency of clinical trials databases.
• Work closely with CROs to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.
• Work closely with Clinical Operations group, biostatisticians, SAS programmers and other staff as appropriate to develop CRF’s to ensure the required information is captured for statistical analysis. Work with biostatistician and SAS programmers to compile and maintain SAS data dictionary.
• Prepare and distribute or facilitate distribution of periodic reports of study status including, CRF completion status, missing pages, query aging, etc.
• Participate in cross functional team meetings as requested and communicate with all departments regarding project statuses/issues, provide ongoing feedback on data management workflows to increase efficiency and provide feedback to CRAs.
• Oversee interactions with outside vendors (e.g. clinical laboratories) on collection, transmittal and transfer of study specific data.
• Develop and update SOP’s associated with the data collection, handling and review processes to meet regulatory compliance and operational needs.
• Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
• Manage multiple and varied tasks, prioritize workload with attention to detail.
• Other duties as assigned.
• Requires a Bachelor’s degree in a related field with a minimum of 5 years’ experience or High School equivalent with at least 7 years’ experience working in a clinical research data handling environment with relevant practical pharmaceutical/biotechnology experience in protocol review/CRF design, EDC clinical study databases and data management.
• Previous vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient Reported Outcome (PRO) and other database technologies.
• Highly detail oriented while maintaining work efficiency, able to prioritize activities across various projects at different study stages.
• Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.
• MedDRA and WHO Drug coding proficiency is preferred.
• Knowledge of SAS is desired.
• Excellent time management, flexibility, ability to coordinate workload and meet established deadlines.
REQUIRED KNOWLEDGE AND ABILITIES:
• Strong verbal and written communication skills are essential.
• Excellent organization and multi-tasking skills.
• Exceptional interpersonal skills and problem solving capabilities.
• Proven meeting planning skills.
• Ability to work effectively across a matrix organization.
• Ability to work independently and prioritize with minimal daily instruction.
• Ability to think strategically in order to improve current processes.