Senior Clinical Data Management Associate
- Capable of handling studies that are complex in scope and volume.
- Effectively interacts with vendors to communicate expectations for study timelines and milestones.
- May lead the design and implementation of the clinical data management process with vendors including data entry, data quality checking, data transfer, reporting, backup, and recovery.
- Demonstrates ability to appropriately delegate tasks to CDA I and CDA II staff members.
- Provide technical and business process input/expertise on new and emerging technologies/vendors for clinical trial execution.
- Demonstrates strong facilitation/Presentation skills.
- Works collaboratively with Programming (Clinical and Statistical), Biomarker Operations, Biostatistics and others such as Biomarker and Clinical Research, Regulatory and Project Management staff to meet project deliverables and timelines for moderately complex biomarker data acquisition, quality checking and reporting.
- Demonstrates the ability to lead multiple studies with minimal supervision
- Ensures completeness, accuracy and consistency of biomarker data structures and data across all projects.
- Working knowledge and experience with FDA/EMA regulations, familiarity with laboratory sample management systems, laboratory information systems (LIMS) and web-based Electronic Data Capture (EDC).
- Provides guidance and training to CROs and vendors on data acquisition requirements.
- Ensures adherence to standard business processes within CDM systems to ensure compliance to regulatory bodies.
- May lead in the design and implementation of clinical data management process with vendors including data entry, data quality checking, data transfer and reporting.
- Reviews study protocols and assist in the planning and implementation of the data management portions of clinical studies.
- Interact with site coordinators, investigators, and field clinical staff in collecting data and resolving queries to meet the protocol requirements in a timely manner.
- Utilizes reports to track study progress and ensure timeliness and quality expectations are met.
- Excellent verbal and written communication skills and interpersonal skills are required.
- The ability to problem solve. Exceptional people/project leadership skills are required.
Education and Experience:
- 5 years of experience and a BS degree.
- 3 years of experience and a MS degree.
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