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
...a dynamic, welcoming, and collaborative workplace, you will be part of a team that contributes to a culture that positively impacts the communities and customers we serve.As a **Security Officer - Hospital Vaccine Response** in **Erie, PA** , you will serve and safeguard...
...address the challenges of the cancer burden faced by the population we serve as we work together to find a cure. As a Genetic Counseling Assistant at the UF Health Cancer Institute (UFHCI) you will be responsible for supporting the Hereditary Cancer Program by...
...standards of a large corporate company while maintaining our small business family style culture.? Essential Job Summary:: The On-Road Technician / Installer is a mobile field service role responsible for installing, maintaining, and repairing compactors, containers,...
...methodsBe willing to work overtime as required to meet company goalsAbility to maintain regular, predictable, and punctual attendancePactiv Evergreen is committed to a diverse and inclusive workforce. Pactiv Evergreen is an Equal Opportunity Employer. All qualified...
...Delivery Van Driver When childhood friends Holly and Shawn stepped away from their corporate careers and started Rook Coffee in 2010, they wanted to make people feel special. Since the beginning, in a 300-square-foot shack, Rook has focused on offering specialty coffees...