Job Summary
Join our dynamic team and make a lasting impact on patient lives. As a Clinical Trial Lead (CTL), you'll lead the charge in executing on groundbreaking clinical evidence that drives our diagnostics business forward and will be a key member of the Clinical Operations team. The CTL is responsible for the execution of clinical trial(s) at the site level, accountable for development and execution of the clinical monitoring plan, study materials, site identification and selection, and clinical research associate (CRA) and site training.

Essential Duties and Responsibilities
• Plans and executes clinical operations for simple to complex clinical trials.
• Manages project-specific work of Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs) in execution of operations, and ensures compliance with GCP, regulations, and procedures.
• Promotes operational efficiency, teamwork and high morale amongst CRAs and CTAs.
• Provides input on protocol design and operational aspects of the trial. Develops clinical monitoring plan(s) and informed consent documents and study tools.
• Develops study specific CRA training materials. Trains CRA team and tracks and maintains documentation of training throughout the life of the project.
• Acts as mentor and co-monitor with CRAs to ensure high quality of deliverables.
• Supports CRAs with site challenges, providing necessary intervention(s), including direct site contacts or on-site visits.
• Supports resource planning and escalates performance and site compliance issues when necessary.
• Leads clinical site start-up activities, such as: site selection, site budget negotiations and contract execution (as needed to support clinical finance), regulatory document collection, and IRB approval.
• Monitors the status of site budget and contract negotiations; tracks and reports monthly clinical trial operations expenses.
• Drives trial conduct and reviews trial activities/enrollment to identify trends/issues related to CRA and site activities; ensures operational aspects are on schedule.
• Develops and utilizes metrics to assure study is running per timelines and goals.
• Presents and participates in Investigator Meetings, other study trainings and meetings as required.
• Manages quality control (QC) of the project Trial Master File (TMF).
• Recommends and implements continuous process improvement ideas for clinical operations.
• Owns and regularly contributes to the development and revision of clinical operations and study management documents, including clinical procedures, tools, and templates.

Qualifications
Education
• Minimum Bachelor’s degree in Life Sciences or equivalent qualification

Experience
• Minimum of 6 years of progressive experience in clinical research within an industrial setting. Experience in an IVD environment is preferred.
• Experience in study management, including managing moderate to complex studies.
• Must have a demonstrated ability to solve problems with innovative solutions along with strong organizational skills.

Skills
• Advanced knowledge of clinical trial practices and regulations.
• Advanced knowledge of clinical operations and monitoring management.
• Advanced knowledge of clinical trial databases.
• Demonstrated ability to lead and influence people without direct authority.
• Flexibility in daily activities and innovative problem solving skills.
• Demonstrated strong project management skills.
• Excellent interpersonal skills.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career.

The annualized base salary range for this role is $118,600 to $158,300 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

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 inclusive of disability and veterans.

#LI-JS1