Clinical Trial Lead

Hologic•Marlborough, MA

1d•$116,500 - $182,200•Hybrid

About The Position

Are you ready to help shape the future of diagnostic innovation? At Hologic, our Diagnostic Solutions R&D teams are advancing breakthrough technologies that improve patient outcomes across women’s health, infectious disease, and oncology. Join our team and play a key role in translating scientific discovery into impactful diagnostic solutions used by clinicians around the world. We are looking to hire an experienced Clinical Trial Lead to join the team. This is a hybrid role in which you’ll be expected to be onsite at our Marlborough, MA office 3 days a week. The Clinical Trial Lead (CTL) is responsible for leading and managing clinical project execution in support of best-in-class, innovative, compliant clinical evidence. 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, site identification and selection, clinical research associate (CRA) and site training, and development of study materials.

Requirements

Minimum Bachelor’s degree in Life Sciences or equivalent qualification
Minimum of 6 years of progressive experience in clinical research within an industrial setting.
Experience in study management, including managing moderate to complex studies.
Advanced knowledge of clinical trial practices and regulations.
Advanced knowledge of clinical operations and monitoring management.
Advanced knowledge of clinical trial databases.
Proficient knowledge of technical computer systems.
Ability to lead and influence people without direct authority.

Nice To Haves

Experience in an IVD environment is preferred.

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.
Generates 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.