San Diego Metro Area,
Job Type: Clinical
Job Number: JN -112018-23139
- Develop and implement strategic vision for data management (DM) group
- Responsible for managing, planning and coordinating the activities of the Data Management group
- Responsible for ensuring the data collected meets the requirements of the study objective and company quality standards.
- Ensure that the Data Management group is aligned with business objectives and complies with FDA requirements.
- Contribute to development of outsourcing strategies and relationships with outsourcing partner and play a key role in identification of quality DM partners including coordinating the review and approval of the Master Services Agreement.
- Manage the clinical data managers within the organization.
- Minimum of 10 years experience in a clinical research data handling environment with relevant practical experience in protocol review/CRF design, clinical study databases and data management and at least 2 years experience managing others.
- Knowledge of industry standards, such as the ICH guidelines, CDASH, 21 CFR Part 11, and FDA guidelines.
- Experience with SAS.
- Excellent time management, ability to coordinate workload and meet established deadlines.