Clinical Trial Manager

About the role

The Clinical Department at Impulse Dynamics (USA), Inc. is responsible for executing clinical studies in compliance with company SOPs, GCPs, and regulatory guidelines. The CTM manages all aspects of the clinical trial team activities for assigned clinical trials, ensuring adherence to GCPs and compliance with applicable SOPs.

Responsibilities

• Write or contribute to the preparation of clinical protocols, amendments, informed consent forms, case report forms, monitoring plans, data management plans, and other clinical research-related documents.
• Proactively coordinate, manage, and oversee various project-level operational aspects of the CTT, including management of trial timeline, budget, resources, and vendors.
• Provide regular updates on trial progress to clinical leadership regarding vendor selection, project plans, trial budget and timeline management, and risk mitigation.
• Lead study startup processes, including conducting Investigator meetings, site selection, and finalizing site clinical trial agreements and budgets.
• Ensure effective project plans are in place and operational, working proactively with the CTT to set priorities in accordance with applicable project plans, company SOPs, ICH/GCP guidelines, and regulatory requirements.
• Escalate potential study risks to clinical leadership when appropriate.
• Lead the CTT working group and vendor status update meetings.
• Track, follow up, and resolve site monitoring issues in a timely manner.
• Maintain quality of vendor deliverables, address quality issues, and identify opportunities to improve training, execution, and quality control across the clinical team.
• Support clinical trial oversight committees (Steering Committee, DSMB, Clinical Events Committee).
• Assist with CRA and third-party vendor training on protocols and practices.
• Develop and maintain good working relationships with investigators and study staff.
• Contribute to writing annual progress reports and final reports to regulators, as required.

Requirements

• Bachelor’s degree or higher in a scientific, clinical, or related field.
• For Associate CTM: Minimum of 2 years of progressive experience in clinical operations, clinical trial management, or project management within the pharmaceutical, biotechnology, medical device, or CRO industries. Experience supporting multicenter clinical studies preferred.
• For CTM: Minimum of 4 years of progressive experience in clinical operations, clinical trial management, or project management within the pharmaceutical, biotechnology, medical device, or CRO industries. Demonstrated experience independently managing clinical studies or major study workstreams.
• Hands-on experience managing or supporting Investigational Device Exemption (IDE) clinical trials is required.
• Working knowledge of FDA regulations, ICH-GCP, and clinical trial best practices.
• Strong project management, organizational, and problem-solving skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Excellent written, verbal, and interpersonal communication skills.
• Proficiency with Microsoft Office applications and clinical trial management systems.
• Prior experience in heart failure and/or cardiac rhythm management clinical studies is strongly preferred.
• Experience managing CROs and external vendors is preferred.

Qualifications

• Must have a valid driver’s license and reliable transportation.
• Must be able to lift up to 25 pounds.
• Must be able to work flexible hours, including evenings and weekends, as needed.

Skills

• Strong leadership and project management skills.
• Excellent communication and interpersonal skills.
• Knowledge of FDA regulations, ICH-GCP, and clinical trial best practices.
• Experience with clinical trial management systems.
• Experience with Investigational Device Exemptions (IDE) and clinical trials.

Benefits

• Annual Base Salary Range: $95,000 - 115,000
• Full Coverage Medical Benefits – Employee + family contribution is 100% covered by Impulse Dynamics.
• Paid Vacation, floating holidays, and sick time.
• Paid Holidays.
• 401k Match (up to 6%).
• Annual bonus eligibility.

Pay

Annual Base Salary Range: $95,000 - 115,000

Schedule

Flexible schedule to accommodate clinical trial needs.