Clinical Program Manager

Clinical Program Manager

HistoSonics is a medical device company, founded in 2009, that has developed a non-invasive, sonic beam therapy platform that uses histotripsy, which is capable of destroying targeted liver tumors. Our mission and passion are to advance the novel science of histotripsy and its powerful benefits, bringing meaningful and transformational change to physicians and their patients.

Location

Remote position, ideally candidates will live in a major metro area with an international airport.

Travel Expectation

Travel (by automobile or air, day trips and overnight stays) up to 25% of the time.

Position Summary

The Clinical Program Manager (Clinical PM) develops, manages and executes global clinical studies in collaboration with the Clinical Affairs team in accordance with applicable regulatory requirements and company’s strategic imperatives. The Clinical PM manages all activities of study design and development, vendor management, site management including qualification, training, activation and monitoring. The Clinical PM will ensure study performance and compliance.

Key Responsibilities

• Responsible for the management of Clinical Trials from inception through Clinical Study Report (CSR) completion.
• Ensure clinical trial activities are completed on time, within budget and in a highly dynamic and complex environment in accordance with appropriate quality standards including ICH/GCP requirements.
• Create and implement study-specific clinical monitoring tools and documents.
• Lead the identification, evaluation, selection, and oversight of clinical trial sites.
• Author and implement operational plans to ensure efficient study enrollment and monitoring activities at clinical sites.
• Review/approve vendor and site invoices and track study budget to forecast, working closely with finance and clinical business operations.
• Responsible for implementation and oversight of Trial Master File for inspection readiness.
• Drive overall process and provide support to cross-functional teams in the development of study documents including study protocols, consent forms and budget templates.
• Serve as lead in the creation of project plans, logs, templates, newsletters, and other documents.
• Review and approve site specific documents (such as informed consent forms, site budgets, monitoring reports).
• Provide study updates and reports, inclusive of study risks and issues.
• Lead internal and external meetings, including Investigator Meetings, conferences, events and study management meetings.
• Responsible for ongoing study data reviews and data cleaning activities.
• Provide oversight of study activities such as site initiation, data quality, interim monitoring and close out activities.
• Support the development of study training to investigators, site staff and internal staff.
• Participate in the preparation and follow up of internal process audits, vendor, and study site quality audits as well as regulatory inspections.
• Other duties as assigned.

Qualifications And Skills

• Bachelor’s degree in relevant area of study.
• Minimum of 2-3 years clinical trial management experience; IDE trial experience preferred.
• Minimum of 5 years experience in the medical device industry REQUIRED.
• Knowledge of, and experience with, the FDA and the EU regulatory environments.
• Excellent written and verbal communication skills.

HistoSonics will not offer sponsorship or take over sponsorship of an employment visa for this position at this time.

Benefits

We offer a comprehensive benefits package for full-time employees. This includes health, dental, and vision insurance, life, short-term and long-term disability insurance, 401(k), paid time off, and more.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Key skills/competency

• Clinical Program Manager
• Clinical Trials Management
• Medical Device Industry
• FDA Regulatory Environment
• EU Regulatory Environment
• ICH/GCP Requirements
• Study Design and Development
• Site Management
• Vendor Management
• Clinical Study Report