Director of Clinical Data Operations
4 days ago
Clinical Dynamix, Inc. is seeking a highly experienced Associate Director of Clinical Data Management to lead the development and execution of clinical data management strategies for our organization. The successful candidate will be responsible for overseeing the start-up and execution of multiple, complex trials with a Contract Research Organization (CRO) and supporting upcoming submissions.
Key Responsibilities- Develop and Lead Clinical Data Management Strategies: Define and implement clinical data management strategies to ensure high-quality data and compliance with regulatory requirements.
- Oversee Trial Execution: Coordinate and manage daily data management and vendor oversight activities for multiple clinical trials to support both the internal project team and the CROs.
- Develop and Implement Data Management Plans: Plan, develop, and implement data management plans, including database design, eCRF development, and data validation guidelines.
- Ensure Data Quality and Integrity: Accountable for ensuring all data quality and timeliness of CDM deliverables are met and aligned with the business goals; Coordinate with all functions to drive data cleaning.
- Manage Clinical Trial Data Queries: Responsible for managing the clinical trial data queries along with the planning and execution of medical coding and SAE reconciliation.
- Maintain Data Integrity: Maintain data integrity in compliance with Good Clinical Practice (GCP), relevant SOPs, and regulatory requirements by reviewing data processes and filing documentation in the trial master file (TMF).
- Partner with Cross-Functional Teams: Partner with cross-functional key stakeholders to meet project deliverables and timelines for clinical data acquisition, quality checking, and reporting.
- Develop and Maintain Data Management SOPs: Develop data management SOPs and processes that align and address business priorities; Uphold a reputation for data integrity and compliance.
- Education and Experience: Requires a Bachelor's degree within a scientific discipline (advanced degree a plus) with a minimum of 10+ years of experience within biotech/biopharma and/or CRO organization.
- Extensive Knowledge and Experience: Extensive knowledge and experience in clinical data management, including direct experience with different Data Management systems and technologies, Electronic Data Capture systems, and CDISC data standards.
- Comprehensive Understanding: Comprehensive understanding of database and dictionary structures, drug development, study conduct processes, GCP, and regulations related to clinical data management, as well as ICH guidelines and FDA/EU regulations.
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