Clinical Data Management Director
$181,500–$258,000 year
On-site · Alameda, California, United States
Job Summary
The Clinical Data Management Director provides strategic and operational leadership for Clinical Data Management activities across solid tumor oncology clinical studies Phase I to IV, ensuring a high-quality database. This role involves accountability for the delivery of clinical trials with various resourcing models and demands excellent organizational skills for resource allocation. The incumbent must demonstrate strong leadership in data management, compliance with standards, and contribute to developing performance metrics. Required qualifications include significant experience in clinical data management, particularly within the biotech or pharmaceutical industry, with a focus on oncology trials, regulatory submissions, and a strong understanding of GCP and related standards.
Required Qualifications
- BS/BA degree in related discipline with a minimum of 13 years of related experience, or MS/MA degree with a minimum of 11 years of related experience, or PhD with a minimum of 8 years of related experience, or equivalent combination of education and experience
- Minimum of 15 years of related experience and/or combination of experience and education/training required
- Excellent understanding of clinical development, quality and regulatory standards (e.g., CDISC)
- Knowledge of Good Clinical Practices (GCP) is essential
- Demonstrated success managing data management activities of Clinical Research Organizations (CROs)
Desired Qualifications
- Experience in Oncology clinical trials preferred
- Experience leading change initiatives preferred
- Demonstrated experience leading global data management activities required
- Experience participating in regulatory submissions and inspections required
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