Senior Manager, Clinical Data Management
Senior Manager, Clinical Data Management
San Diego, CA - Hybrid
$120,000 - $160,000
A clinical-stage biotechnology company in San Diego is focused on developing therapies for rare genetic disorders. Utilizing advanced gene editing and molecular biology techniques, the company aims to create targeted treatments that address the underlying causes of these conditions. With a strong pipeline and significant backing from investors, the company is well-positioned for growth and innovation in genetic medicine. Joining this team means contributing to important advancements in the field and working in a collaborative environment.
Responsibilities
- Lead and manage clinical data management activities for multiple clinical trials
- Oversee the design, implementation, and maintenance of clinical databases
- Ensure data quality and integrity through rigorous data review and validation processes
- Collaborate with CROs, vendors, and internal teams to ensure timely and accurate data collection and reporting
- Develop and maintain data management plans, CRF guidelines, and other essential documentation
- Monitor data management timelines and deliverables to ensure project milestones are met
- Provide training and support to clinical data management staff and study teams
- Implement and oversee data cleaning and query resolution processes
- Ensure compliance with GCP, FDA, and other regulatory requirements
- Participate in the preparation of data for regulatory submissions and clinical study reports
- Identify opportunities for process improvements and implement best practices in data management
Qualifications
- Bachelor's degree in a relevant field required; advanced degree preferred
- Minimum of 5 years of experience in clinical data management within the biotech or pharmaceutical industry
- Experience with rare genetic disorders or similar therapeutic areas is highly desirable
- Strong knowledge of clinical data management systems and tools
- Excellent organizational and communication skills
- Ability to work effectively in a fast-paced, team-oriented environment
If you are passionate about clinical data management and making a difference in patients' lives, we encourage you to apply.
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