Clinical Trial Manager

Clinical Trial Manager - Helios Group of Companies

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 support 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:

• Manage day-to-day execution of assigned clinical trials from study start-up to close-out, ensuring milestones are met.
• Collaborate on the development of study documentation, including protocols, ICFs, and reports.
• Collaborate with cross-functional teams, including regulatory affairs, research and development, biostatistics, and data management, to ensure successful trial execution.
• Serve as the primary point of contact for clinical trial sites and CROs, monitoring performance and compliance.
• Monitor study progress, identify and resolve issues, and proactively communicate updates to stakeholders.
• Track 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.
• Oversee the collection, monitoring, 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.
• 4+ years of experience in clinical trial management or relevant clinical operations role, 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.
• 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.
• Experience with international clinical trials.
• Experience with regulatory submissions and interactions.

Work Authorization Requirements:

• Candidates must be legally authorized to work in the United States without requiring future visa sponsorship (e.g., H-1B, F-1 OPT, etc.) at the time of hire or at any point in the future.
• This role does not offer sponsorship for work authorization.

To Apply:

Submit your resume and a cover letter highlighting your relevant experience and achievements to [email protected].

Equal Opportunity Employer:

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

Pay: $100,000.00 - $130,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Education:

• Bachelor's (Required)

Experience:

• Clinical trials: 4 years (Required)
• Good Clinical Practice: 4 years (Required)

Ability to Commute:

• Natick, MA 01760 (Required)

Work Location: In person