Assist with the implementation and management of clinical studies to support marketing and
regulatory efforts. Will be direct contact to several clinical research sites. Will require
20 to 30% travel.
Assist with the development of clinical strategy which includes the preparation of clinical
protocols, investigational plans, and study material (e.g., case report forms, study
Ensure clinical research is conducted in accordance with 21 CFR Part 812, 50 and 56
Coordinate data analysis and prepare clinical reports to support regulatory filings, internal
reports, manuscripts and newsletters to participating institutions.
Evaluate and approve clinical sites to ensure compliance with applicable regulatory
Negotiate and prepare study contracts with clinical sites.
Manage clinical research associates as well as data management process with CRO
Conduct site initiation visits and provide training to the clinical study personnel
Participate in investigator meetings
Audit CRO records and monitor clinical data at study institutions
Participate as a member of Product Design Review Teams as the Clinical representative
Prepare internal clinical operating procedures
Prepare and review clinical sections of regulatory submissions
EDUCATION AND EXPERIENCE:
BS degree in Science/Health discipline
Minimum of four years experience with clinical trials, either in industry or academic setting
Must have strong working knowledge of US regulations
Certification in clinical research a plus
Ability to interact with multiple departments & functions and manage completion of multiple
Ability to prioritize and display initiative and flexibility
Must be detail oriented and possess strong organizational skills
Must have a strong understanding of the fundamentals of clinical research
Must be proficient with PC and associated hardware
Must have strong communication skills including verbal, technical and written skills
Cytyc is an Equal Opportunity Employer committed to a diverse workforce. Qualified individuals
please submit resume and salary history via our Online Application page. Principals only
please. Unsolicited resumes from third party agencies will not be accepted.
Please include Job Code on all correspondence.
Job Code: MCAG-MON