Executive Director of Clinical Data Systems

About the Company

Accomplished biotechnology (BioTech) company developing innovative treatments

Industry Biotechnology

Type Privately Held

About the Role

The Company is seeking an Executive Director of Clinical Data Systems to lead strategic initiatives in the acquisition and management of clinical data, ensuring compliance with global standards and regulations. The successful candidate will be responsible for developing and implementing advanced policies and procedures to enhance the efficiency of clinical data management. This role involves driving innovation in data collection processes, collaborating with cross-functional teams to improve data quality and operational efficiency, and providing leadership in vendor management to ensure controlled and compliant data delivery. The Executive Director will also represent the Clinical Data Management department in executive-level discussions and decision-making and must ensure adherence to industry standards, including CDISC and Good Clinical Practices (GCP).

Applicants for the Executive Director position must have a Bachelor's degree in a relevant field, with an advanced degree preferred, and a minimum of 18 years of experience in clinical data management within the Biotech/Pharmaceutical industry. A proven track record in leading global data management teams and initiatives, extensive experience with regulatory submissions and compliance processes, and strong knowledge of CDISC standards, GCP, and clinical development protocols are essential. The role requires exceptional leadership skills, the ability to inspire and guide teams, and a demonstrated ability to manage change and drive innovation in complex environments. Excellent analytical, organizational, and communication skills are also necessary to support the management of departmental budgets and resources effectively.

Travel Percent Less than 10%

Functions

Data Management/Analytics Non-Profit Management