Clinical Trial Manager

Location
Santa Clara, California
Salary
Competitive
Posted
Dec 06, 2017
Closes
Jan 06, 2018
Ref
18043908
Discipline
Medicine
Contract Type
Full Time
Job Type
Manager
Date Posted: 05/Dec/17



Requisition:



Job Title: Clinical Trial Manager



Description: 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 .



Take the lead for clinical studies of in-vitro diagnostic devices, as the Pathology division, former DAKO, of Agilent Technologies runs clinical studies to ensure, delivery of high quality diagnostic devices to the market. We are looking for a pioneering spirit with responsibility 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, as well as assisting in ensuring a well-functioning QMS . 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. Be a key player for a company that is a market leader in delivering innovative technologies, solutions and services to wide range of customer



- 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



- Design studies for 510K or PMA approval at FDA



- Assist and drive actions, as we are getting ready for implementing the new European In Vitro Diagnostic Device Regulation



- Ensuring success through collaboration with your team on your work.



Qualifications:

- Bachelors degree in biological or biochemical sciences required, with equivalent job experience.



- Advanced degree and/or clinical certification preferred



- A minimum of 8 years of Clinical Trials experience for diagnostics, medical device and/or biological products, including 3 years of management experience.



- A solid understanding of project management and familiar with project management tools.



- Experience in CRO/vendor management and contracting.



- Understand requirements of various controlling bodies and framework.



- Knowledge of IVD, pathology and/or oncology is preferred.



- Experience in working in parallel projects teams.



- High work capacity may be required at certain times in high priority projects.



- The ability to organize and motivate others.



- Flair, enthusiasm and leadership when faced with challenges.



Agilent Technologies, Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases.



For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster available here:









Agilent Technologies, Inc., is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please contact +1- (US and Canada only) or email . EOE AA M/F/Vet/Disability



Company:



Business: Global Infrastructure



Job Category: Quality/Regulatory



Job Sub-Category: Clinical



Region: Americas



Country or Area: United States



State/Province: California



Town/City: Santa Clara



Shift: Day Job



Job Type: Experienced



Schedule: Full-time



Travel Required: Yes, 25% of the Time



Duration

(Temp Positions Only): Not applicable



HR Country Location: United States



HR Town/City Location : Santa Clara