Be a part of the future of Precision Medicine! Our mission is to improve the human condition by bringing the power of precision medicine to labs, partners and patients globally
Agilent inspires and supports discoveries that advance the quality of life. We provide life science, diagnostic and applied market laboratories worldwide with instruments, services, consumables, applications and expertise. Agilent enables customers to gain the answers and insights they seek ---- so they can do what they do best: improve the world around us. Information about Agilent is available at www.agilent.com.
In the Companion Diagnostics Business (CDx), our team partners very closely with leading pharmaceutical companies to develop, manufacture and commercialize highly regulated medical devices which are critical for physicians to help select therapies for their patients.
Become a part of a growing and dedicated team that does truly inspiring work in the field of Precision Medicine. Our employees are passionate about their contributions because there is a very direct connection to helping patients with cancer.
We are searching for an experienced Clinical Trial Manager to join the Companion Diagnostics (CDx) Business at Agilent.. As a Clinical Trial Manager your main responsibilities will be to plan, coordinate and manage the day-to-day running of clinical studies for cancer in vitro diagnostics (IVDs), focused on CDx clinical trials, to support regulatory applications and scientific marketing activities. You will develop and design database and Data Report Forms in collaboration with Clinical Affairs Specialists, and prepare and follow-up on queries. Your work includes identifying, evaluating and qualifying clinical study sites, assist with site contracting, vendor/CRO management, training and initiation of clinical lab sites, ensure monitoring, responsibility for study files, guiding projects in conforming to requirements, and acting as point of contact (internal and external) for study related issues.
- The Clinical Trial Manager will assist in distribution of trial related information to relevant persons/bodies, coordinate EC/IRB approvals, and identify and resolve problems at study sites.
- Responsible for overall clinical study management, including planning, communication, coordination and practical tasks for the studies.
- Coordinates Ethical Committee and Institutional Review Board notifications
- Creates, maintains and oversees study files and archiving.
- Manages testing laboratories including selection of laboratories for the studies.
- Manages Clinical Research Organizations and ensures monitoring of studies, data collection and handling. Prepares, revises and maintains procedures for the conduct of studies.
- Reduces broad concepts, business strategies into structure projects
- Leads the design/ delivery of new programs/ solutions; is the key technical contributor
- Solves complex, high impact program/ project design problems
Geographic location: Santa Clara, CA or Carpinteria, CA