Hologic, Inc. is a leading developer, manufacturer and supplier of premium molecular diagnostic products and services that are used to diagnose human diseases, screen donated human blood and to aid in biomedical research. Hologic is also a leader in the development, manufacturing and sales of medical imaging systems and biopsy devices as well as surgical and treatment products, with an emphasis on serving the healthcare needs of women. Our business is dedicated to impacting the lives of people across the globe through the early detection of disease, improved diagnosis and less invasive treatments. There’s never been 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 headquartered in Massachusetts and have centers of operation across North America, Europe, Central America, Australia and Asia. We have the strength and resources of a billion dollar company and the vision of leaders committed to a broad spectrum of health issues. We are rapidly growing and yet we have never been more focused – on our people, on our growth, on our future.
Hologic is seeking an experienced Program Leader with a proven track record of independently, passionately and effectively driving the planning and execution of clinical studies. Duties and responsibilities include:
Develops and executes clinical studies which includes the preparation of clinical protocols, informed consent forms, investigational plans, study materials (e.g., training materials, case report forms, study files, supplies requirements).
Establish project objectives and work plans including budgets and resource requirements. Delegate assignments to functional area team members and track key project activities to successful completion.
Demonstrated ability to proactively identify and resolve product and project risks.
Ensure clinical research is conducted in accordance with FDA Regulations, GCPs, ICH guidelines, International regulations and internal SOPs
Evaluate and approve clinical sites for studies to ensure compliance with applicable regulatory regulations.
Manage and oversee site initiation and training to clinical study personnel at sites
Manage on-going monitoring activities: scheduling, report review and approval
Negotiate and prepare study contracts with clinical sites
Experienced leader well-versed in managing within a matrixed organization
To perform this job successful, 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:
Knowledge of FDA Regulations, GCPs, ICH guidelines, International regulations.
Experience in management of project risks.
Strong communication and teamwork skills.
Must possess excellent relationship building skills with team members, luminary doctors and senior leaders accessing their needs and ask the right questions to surface essential requirements information.
High degree of competency in Microsoft suite.
BS Degree in health related field.
PMP Certification and international experience desirable
5+ years of experience in clinical research and project management.
Experience leading cross-functional teams and projects.
Previous experience managing clinical studies in Women’s Health.
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