Clinical Trial Lead

Hologic, Inc.; San Diego (CA); Hybride; USD 117 000 - 182 000; Plein temps

Avantages offerts par ce poste

Hybrid work arrangement

Résumé du poste

Hologic, Inc. is seeking an experienced Clinical Trial Lead to drive the execution of clinical studies in a hybrid setup across Marlborough, MA or San Diego, CA.

This role requires in-office presence at least three days per week and oversight of CRA/CTA teams, monitoring plans, site selection, budgeting, and regulatory documents. You will ensure compliance with GCP and drive study metrics, training, and continuous process improvements, contributing to leading diagnostics programs in women’s

Qualifications

• Experience in clinical research in an industrial setting.
• Experience in IVD environment preferred.
• Experience in study management for moderate to complex studies.

Responsabilités

• Plan and execute clinical operations for simple to complex trials.
• Manage CRAs and CTAs to ensure compliance with GCP and procedures.
• Develop monitoring plans and study tools including ICFs.
• Train CRA team and maintain documentation of training.
• Mentor CRAs and provide on-site support as needed.
• Monitor site budgets and contract negotiations; report expenses monthly.
• Drive trial conduct and identify trends in CRA/site activities.
• Create metrics to track timelines and study goals.
• Support investigator meetings and TMF quality control.

Connaissances

Advanced knowledge of clinical trialPr

Advanced knowledge of clinical ops

Advanced knowledge of clinical trialDB

Technical computer systems

Lead and influence without authority

Formation

Bachelor’s degree in Life Sciences or equivalent qualification

Description du poste

Clinical Trial Lead

Marlborough, MA, United States

San Diego, CA, United States

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 for an experienced Clinical Trial Lead to join the team in Marlborough, MA or San Diego, CA. This hbrid position requires a minimum of three days per week in office.

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.

Additional Requirements:

• Location: Marlborough, MA or San Diego, CA
• Hybrid: 3 days a week minimum in office

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.

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.

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