Senior, Clinical Data Manager
San Diego, CA
We are currently searching for a skilled professional to join a well-known client’s team as a Senior Clinical Data Manager in San Diego, CA. The Senior Clinical Data Manager will coordinate and complete data management activities to meet project timelines, and work closely with Clinical Operations group, biostatisticians and SAS programmers. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Perform codingreviewfor adverse events, medical historyand concomitant medications and coordinate medical monitor review and approval of medical coding with the clinicalstudymanager.
- Work closely with CROs to prepare and ensure proper execution of data management plansandmanage data management projects from beginning to end.
- Coordinate and complete data management activities to meet project timelines and communicate status to respective team members.
- Participate in cross functional team meetings as requested andcommunicate 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 meetregulatory compliance and operational needs.
- Participate in clinical review and validation of statistical outputs used in the preparation of final reports.
- Minimum of5years’experiencein a clinical research data handling environment.
- 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.
- Knowledge ofSASis desired.
- Excellent time management,flexibility,ability to coordinate workload and meet established deadlines.
- 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.
- Requires a Bachelor’s degreein a related field.