Location: Remote
Summary
The Associate Director, Clinical Data Management, will play a crucial role in our data management efforts, ensuring the accuracy, consistency, and integrity of clinical data. This position involves leading and overseeing all aspects of data management, from planning and coordination to execution and quality control. The successful candidate will be responsible for managing relationships with external partners and collaborating across cross-functional teams to ensure data deliverables and expectations are met.
Job Responsibilities
Essential duties and responsibilities include the following. Other duties may be assigned.
- Provide data management leadership, insight, and support to all internal and external projects and clinical trials.
- May simultaneously function as lead Clinical Data Manger for multiple clinical trials.
- Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.
- Manage and provide oversight of data management personnel and activities of CROs and vendors.
- Ensure CRO adherence to project timelines, from study startup to study closeout, while maintaining high quality and integrity of deliverables.
- Engage in cross-functional meetings, providing updates on project status, issues, and milestones.
- Review data using listings and visualization tools for performance and quality reporting, conducting reviews within studies and across multiple studies for trend analysis.
- Lead interactions with third party vendors (e.g., clinical laboratories) on collection, transmittal, and transfer of study specific data.
- Proficient in clinical systems including EDC, IVRS, CTMS, eTMF, and other clinical project management tools; ability to learn new systems as needed.
- Contribute to SOP development and updates to meet regulatory compliance and operational needs.
- 10% of travel required.
Education and Experience
- Bachelor’s degree in Life Science, mathematics, or health-related fields preferred.
- Minimum of 6 years data management experience in pharmaceutical/biotech/CRO industry; extensive hands-on experience in all aspects of data management.
- Experience in the Oncology therapeutic area is preferred.
Skills and Qualifications
- Proven ability to manage CRO relationships and oversee data management deliverables.
- Strong knowledge and experience of EDC systems (Medidata RAVE preferred).
- Solid knowledge of GCP, CDISC/CDASH data structures, ICH guidelines and FDA regulations.
- Excellent verbal and written communication skills.
- Strong analytical and problem-solving abilities.
Physical Demands
While performing the duties of this job, the employee is regularly required to sit, reach with hands and arms, and talk or hear. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision and distance vision.
Work Environment
The noise level in the work environment is usually moderate.
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