Hologic is seeking a Clinical Trial Lead responsible for leading and managing the clinical operations of clinical trials.
Duties & Responsibilities:
Oversees clinical monitoring activities of moderate to complex clinical trials
Provides clinical operations guidance to Clinical Trial Assistants (CTAs) and Clinical Research Associates (CRAs) as needed
Promotes operational efficiency, teamwork and high morale amongst CTAs and CRAs
Communicates monitoring and site management updates or issues to team
Proactively prevents and identifies issues related to the clinical portion of the study, including study processes, monitoring or site issues
Develops clinical monitoring strategies for assuring study timelines are met and assuring quality deliverables
Sets up and maintains Clinical Monitoring tracking tools and develops study tools and templates for monitors and site personnel
Develops the study Clinical Monitoring Plan and ensures CRA compliance
Reviews monitoring visit reports and assures adherence to study timelines for report submission and finalization
Participates in site start-up activities, including site selection and regulatory document collection, review, approval and tracking, and the development of informed consent forms, template source documents, study manual, regulatory binder and other study related documents
Develops study specific CRA training materials. Trains CRA team and tracks and maintains documentation of training throughout the life of the project
Works with Clinical Program Management to identify and manage appropriate CROs and study suppliers
Generates and utilizes metrics tools to assure study is running per timelines and to alert CRAs to potential issues (e.g., CTMS, DM Query Trends, Outstanding Monitoring Reports)
Works closely with line and department management for resourcing issues and escalates pertinent CRA performance and site compliance issues when necessary
Presents and participates in Investigator Meetings, other study trainings and meetings as required
Act as mentor and co-monitor with CRAs to ensure high quality as required
Assist with the monitoring of difficult sites or studies that may be too challenging for a less experienced CRA
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the basic knowledge, skills, and/or abilities required:
Advanced knowledge of clinical trial practices and regulations.
Advanced knowledge of clinical monitoring management and trial design.
Advanced knowledge of clinical trial databases.
Proficient computer skills
BA or BS degree
8-10 years of related experience
Agency and Third Party Recruiter Notice:
Agencies that submit a resume to Hologic must have a current executed Hologic Agency Agreement executed by a member of the Human Resource Department. In addition Agencies may only submit candidates to positions for which they have been invited to do so by a Hologic Recruiter. All resumes must be sent to the Hologic Recruiter under these terms or they will not be considered.
Hologic, Inc. is proud to be an Equal Opportunity Employer & VEVRAA Federal Contractor
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company's core business units focus on diagnostics, breast health, GYN surgical, and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure.
There has never bee...n a more exciting time to join us. Bright people, working together to pioneer advances in human health care, have created Hologic's success. Our company believes that people are our greatest asset and only by recruiting, hiring, developing and retaining the most talented employees can we continue to be successful. Our work atmosphere is stimulating, innovative and customer focused. We provide employees with state-of-the art tools and technology, a collaborative and passionate work environment and the ability to make a dramatic difference in the world of healthcare.
We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future.