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Senior Clinical Trial Manager

3002354 We are searching for an experienced Clinical Trial Manager to join the Companion Diagnostics (CDx) Business at Dako, An Agilent Technology Company. 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 torelevant persons/bodies, coordinate EC/IRB approvals, and identify and resolve problems at study sites. 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. Your knowledge of cancer diagnostics and ability to self-educate where applicable. 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 RegionAmericasRequirements Bachelor s degree in biological or biochemical sciences required, with equivalent job experience.   Advanced degree and/or clinical certification preferred.  A minimum of 10 years of Clinical Trials experience for diagnostics, medical device and/or pharmaceutical/biological products (8 years of Clinical Trials experience if 2 years of IVD experience included). A solid understanding of project management and familiar with projectmanagement 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.
Salary Range: NA
Minimum Qualification
11 - 15 years

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