Clinical Trial Manager

Impulse Dynamics (USA), Inc. is a fast-growing medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation, or CCM™ , delivered by the company’s Optimizer® Smart System. CCM is a first‑of‑a‑kind, proprietary, life‑changing treatment alternative for a vast population of heart failure patients across the globe. With global headquarters in Marlton, N.J., the company has additional offices in Frankfurt, Germany. The Clinical Department executes clinical studies in full compliance with company standard operating procedures, good clinical practices, and applicable regulatory guidelines. It coordinates with Regulatory, Commercial, Legal, Finance, and other departments to oversee all aspects of the study. This role is part of that department and will be committed to advancing heart failure treatment. 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 project‑level operational aspects of the clinical trial team, including trial timeline, budget, resources and vendors. Provide regular updates on trial progress to clinical leadership, covering vendor selection, project plans, budget and timeline management, and risk mitigation. Lead study startup processes, including the investigator meeting, site selection, and finalization of site agreements and budgets. Ensure effective project plans are in place and work proactively with the team to set priorities in accordance with SOPs, ICH/GCP guidelines and regulatory requirements. Escalate potential study risks to clinical leadership when appropriate. Lead the team working group and vendor status update meetings. Track, follow up and resolve site monitoring issues in a timely manner. Monitor vendor deliverable quality, address issues and identify opportunities to improve training, execution and quality control across the clinical team. Support all activities related to 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. Qualifications Bachelor’s degree or higher in a scientific, clinical or related field. Associate CTM: Minimum of 2 years progressive experience in clinical operations, clinical trial management or project management within the pharmaceutical, biotechnology, medical device or CRO industries. Experience supporting multicenter studies preferred. CTM: Minimum of 4 years 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. Compensation & Benefits Annual Base Salary Range: $95,000 - 115,000 Full coverage medical benefits – employee and family contributions are 100% covered by Impulse Dynamics. Paid vacation, floating holidays and sick time. Paid holidays. 401(k) match up to 6%. Equal Opportunity Employer Statement Impulse Dynamics is an equal opportunity employer. We are committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. Employment decisions are based on merit, qualifications, and abilities. Discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information or other protected status is prohibited. This policy extends to all terms, conditions, and privileges of employment and the use of all company facilities. #J-18808-Ljbffr Impulse Dynamics