Clinical Trial Lead

Hologic, Inc.; Marlborough (MA); Hybrid; USD 117,000 - 182,000; Full time

Job summary

Hologic, Inc. in Marlborough, MA seeks a Clinical Trial Lead to drive project execution for innovative, compliant clinical evidence across diagnostics.

This hybrid role requires onsite presence three days per week and oversight of trial activities, CRA/CTA teams, and the development of study materials. Responsibilities include drafting monitoring plans, CRA training, site start-up oversight, budget tracking and TMF quality control, with opportunities to continuously improve processes to meet

Qualifications

• 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 an IVD environment is preferred.
• Experience in study management, including managing moderate to complex studies.

Responsibilities

• Plans and executes clinical operations for simple to complex clinical trials.
• Manages project-specific work of CRAs and CTAs in execution of operations, ensuring compliance with GCP, regulations, and procedures.
• Promotes operational efficiency, teamwork and high morale amongst CRAs and CTAs.
• Develops study specific CRA training materials and trains CRA team.
• Leads site start-up activities, including site selection, budget negotiations and contract execution.
• Monitors site budget and contract negotiations; tracks and reports monthly trial operations expenses.
• Drives trial conduct and reviews trial activities to identify trends/issues related to CRA and site activities.

Skills

Advanced knowledge of clinical trial…

Clinical operations

Monitoring management

Leadership without authority

Education

Bachelor's degree in Life Sciences

Tools

Clinical trial databases

Technical computer systems

Job description

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.

Essential Duties and Responsibilities

The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

• 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.

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.

Skills

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.

The annualized base salary range for this hourly role is $116,500 to $182,200 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Why 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.

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Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.