Director of Clinical Data Systems
About the Company
Join a respected biotechnology company dedicated to developing innovative treatments that make a difference.
Industry
Biotechnology
Type
Privately Held
About the Role
We are looking for a dynamic Director of Clinical Data Systems to lead strategic and operational initiatives in acquiring clinical data across all trial phases. In this pivotal role, you will be responsible for developing and maintaining policies, procedures, and data standards that maximize the use of electronic data capture systems, enhancing high-quality data collection.
Key responsibilities include managing external vendors to ensure compliant data delivery and representing clinical data management in senior leadership discussions. You will collaborate closely with senior leaders across Research and Development to drive innovation and efficiency in data collection processes while adhering to global regulatory requirements and company policies.
The ideal candidate will possess a Bachelor's degree in a related discipline alongside a minimum of 18 years of relevant experience in the biotech or pharmaceutical industry, particularly in oncology clinical trials. A proven track record in leading global data management and technical teams, coupled with a strong understanding of regulatory submissions and inspections, is essential. Familiarity with CDISC standards and Good Clinical Practices (GCP) is highly desirable.
We seek an individual with excellent analytical and business communication skills, capable of inspiring and influencing teams through rapidly changing challenges. Additional responsibilities include driving the vision for optimized clinical data collection utilizing advanced technologies, overseeing the management of data acquisition activities from start to finish, and leading initiatives focused on data standardization to ensure regulatory compliance.
Travel Percent
Less than 10%
Functions
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