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Senior clinical data manager

Pave Talent

This is a Full-time position in San Diego, CA posted December 17, 2019.

Senior Clinical Data Manager Reports To Senior Director of Clinical Operations OverviewThe Senior Clinical Data Manager is responsible for providing leadership and oversight of data management activities to ensure the accuracy and consistency of clinical databases for subsequent analysis and reporting.

This position has a leadership role to proactively develop plans for the utilization of EDC and paper CRF system processes and other clinical data applications that allow for internal control of clinical databases.

Responsibilities of the Senior Clinical Data ManagerEnsure the clinical data collected meets the requirements of the study objective and company quality standards.

Assist in the development and implementation of a strategic vision for clinical data management (DM) group Assist with implement DATATRAK Work closely with CROs as needed, to prepare and ensure proper execution of data management plans and manage data management projects from beginning to end.

Work closely with the 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 the SAS data dictionary.

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 and Medical Monitor.

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 trial databases.

Experience with paper CRF as well as EDC systems.

Datatrak experience is a plus Lead interactions with outside vendors (e.g.

clinical laboratories) on collection, transmittal, and transfer of study-specific data and data transfer specifications.

Develop, update, and implement SOP’s associated with the data collection, handling and review processes to meet regulatory compliance and operational needs.

Work closely with corporate Quality team Mentor team members by resolving problems and providing DM guidance.

Key Qualifications5+ Years of experience in Clinical Data Management Experience implementing or utilizing DATATRAK is highly preferred but not required Strong pharmaceutical/biotechnology experience in protocol review/CRF design, EDC (and paper) clinical study databases and data management.

Previous leadership of vendor management experience using Interactive Web Response System (IWRS), Imaging, Patient-Reported Outcome (PRO) and other database technologies.

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.

SAS programmer would be a plus.

ProficienciesHighly detail-oriented while maintaining work efficiency, able to prioritize activities across various projects at different study stages.

Excellent time management, flexibility, ability to coordinate workload and meet established deadlines.

Rewards & Benefits Annual performance bonus of 15% PTO Health, Dental, & Vision Insurance Flexible Spending Account (FSA) 401(K) Plan w/ employer contributions Tuition Assistance Pave Talent is an Equal Opportunity Employer.