Clinical Trials Manager 9/10/2016
JOB DESCRIPTIONAPPLY 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 www.agilent.com.
We are a global leader in diagnostics and genomics solutions for research and clinical laboratories. Hospitals and research laboratories worldwide use Agilent s Dako reagents, instruments, software and expertise to make accurate tissue-based diagnoses and determine the most effective treatment for cancer patients.
Geography: Carpinteria, CA, centrally located within 20 miles of Santa Barbara and Ventura.
We are looking for a Clinical Trials Manager to join Medical & Clinical Affairs at Dako. As a Clinical Trials 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, especially Companion Diagnostics (CDx) to support regulatory applications and scientific marketing activities. You will develop and design database and Data Report Forms in collaboration with Clinical Trial Managers, 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, 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. You may supervise others.
You will be measured on:
* Your professional interactions and communication skills with study sites and pharmaceutical partners.
* Your ability to work in a fast moving self-driven team.
* Your ability to organize and coordinate documentation related to clinical trials running globally.
* Bachelor s degree (Advanced degree preferred) or equivalent education and experience
* A minimum of 8 years of Clinical Trials experience for diagnostic, medical device or pharmaceutical products.
* 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 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.
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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 +1-262-754-5030 (US and Canada only) or email firstname.lastname@example.org. EOE AA M/F/Vet/Disability.