Director of Clinical Research
Location Bedford, MA, US
Department Name Clinical - Breast Health
Shift Information
Summary of Duties and Responsibilities
The Director of Clinical Research will oversee the management of clinical research for all divisions of Breast Health
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This position will work closely with the CTO and interact with Breast Health business units to include Advanced Technology, Imaging Science, Product Marketing and Management, Engineering and Regulatory
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Regulatory: Work with regulatory to design and implement clinical study designs for FDA PMA and 510k Submissions Assure that all studies conducted are according the IRB, FDA IDE 21 CFR 812, HIPPA and global regulations
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Work with clinical partners to design and oversee the implementation of non-regulatory medical device clinical studies for Advanced Technology, Engineering and Imaging Science
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Work with Statistician to design studies that provide statistical significance to support regulatory and non-regulatory clinical trial aims
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Work with principal investigators to establish policies/procedures to maintain timelines and to ensure Good Clinical Practice Guidelines are followed
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Manage the multi-functional clinical studies team meetings forboth domestic and international
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To the extent that it supports Hologic’s goals, work with clinical investigators in outside grant efforts
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Support publication efforts of clinical investigators
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Work with support staff to implement and see through to fruition, all clinical trials.
Qualifications
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Should be able to move between regulatory and non-regulatory environments in implementing clinical trials to suit the companies needs.
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Should have a thorough understanding of Institutional Review Boards/processes.
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Should have a working knowledge of guidelines set forth by the FDA, to include at least Investigational Device Exemptions, Code of Federal. Regulations 21 Part 812, Health Insurance Portability and Accountability Act (HIPAA) and be familiar with global regulations.
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The ability to interact and communicate effectively with customers in English.
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Organizational skills will be required for managing time during periods of heavy customer calls in order to ensure customer satisfaction.
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Must be willing to work in a fast paced, interrupt driven environment, while handling multiple concurrent tasks.
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80-90% travel either to customer sites or the appropriate Hologic facility.
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A minimum of 5 years experience in clinical research, with
emphasis in breast cancer research. Preferred.
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A minimum of 5 years experience in coordinating, organizing
and implementing clinical trials and in data collection and analysis
for manuscript development/grant submission.
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Should be familiar with established quality assurance
guidelines in the collection of clinical data and/or administration of
clinical studies.
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Should be able to establish standard operational procedures
for conducting clinical trials.
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Applicant should be familiar with the management of adverse
events, patient non-participation, protocol deviation and study
monitoring.
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Familiarity with CPT coding process, and have some experience
with insurance reimbursement as it relates to clinical data collection.
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Is well versed in BI-RADS® terminology for all breast imaging.
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Has excellent inter-personal skills to interface and develop
clinical sites.
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Understands the tenets of Good Clinical Practice in conducting
clinical trials.
Education
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Master’s degree or PhD with 3-5 years in medical device research
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BA/BS and 10+ years clinical research work experience may be accepted
Experience
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Experience in designing clinical studies with an understanding of statistical analysis and application.
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Experience in Good Clinical Practice Guidelines
Specialized Knowledge
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Strong clinical background preferred in Breast Imaging
