About Helios Group of Companies:

We have been innovators in the field of tissue repair and regeneration for over 20 years. Our biomedical devices have benefited hundreds of thousands of patients worldwide. Our current product pipeline extends this legacy to drug delivery and injectable formulations in multiple medical indications.

Job Summary:

We are seeking a highly motivated and experienced Clinical Trial Manager to lead and execute clinical trials for our innovative drug-device combination products and Class III medical devices. The Clinical Trial Manager will be responsible for the overall planning, execution, and close-out of assigned clinical trials, ensuring adherence to regulatory requirements, Good Clinical Practice (GCP), and company SOPs. This role requires strong project management skills, excellent communication abilities, and a proven track record of successfully managing complex clinical trials.

Responsibilities:

Lead and manage all aspects of assigned clinical trials, from study start-up to close-out, within established timelines and budgets.

Develop and maintain study documentation, including protocols, informed consent forms, clinical study reports, and other required documents.

Collaborate with cross-functional teams, including regulatory affairs, research and development, biostatistics, and data management, to ensure successful trial execution.

Select, train, and oversee clinical trial sites and investigators, ensuring compliance with study protocols and regulatory requirements.

Monitor study progress, identify and resolve issues, and proactively communicate updates to stakeholders.

Oversee and manage vendors, including Clinical Research Organizations (CROs), to ensure successful trial execution.

Manage clinical trial budgets and resources effectively.

Ensure compliance with all applicable regulations, including FDA regulations (21 CFR Part 812, etc.), ICH GCP guidelines, and company SOPs.

Conduct regular site visits to monitor study and data quality.

Oversee the collection, review, and management of clinical data.

Contribute to the development and improvement of clinical trial processes and procedures.

Participate in regulatory submissions and interactions as needed.

Mentor and train junior clinical trial staff, as applicable.

Qualifications:

Bachelor's degree in a scientific or related field; advanced degree preferred.

Minimum of 5 years of experience in clinical trial management, preferably with drug-device combination products and/or Class III medical devices.

In-depth knowledge of FDA regulations, ICH GCP guidelines, and other relevant regulatory requirements.

Proven ability to manage complex clinical trials, including budget management and vendor oversight.

Strong project management skills, including planning, execution, and problem-solving.

Excellent communication, interpersonal, and organizational skills.

Demonstrated adaptability to lead decision-making and is driven.

Ability to work effectively in a fast-paced small company cross-functional team environment.

Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).

Certification as a Clinical Research Professional (e.g., ACRP, SoCRA) is a plus.

Preferred Qualifications:

Experience with biomedical devices is highly desirable.

CRO experience is greatly appreciated.

Experience with international clinical trials.

Experience with regulatory submissions and interactions.

To Apply:

Submit your resume and a cover letter highlighting your relevant experience and achievements to careers@helioscardio.com.

Equal Opportunity Employer:

We are an equal-opportunity employer and encourage candidates of all backgrounds to apply.