Associate Clinical Trial Manager
Impulse Dynamics · Marlton, NJ ·
- Employment
- Contract
- Category
- Management
- Experience
- 2+ years
Clinical Trial Manager
Marlton, NJ
Hope is Here!
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 TM, which is 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 is responsible for executing clinical studies in full compliance with company standard operating procedures, good clinical practices, and applicable regulatory guidelines. Clinical plays a significant role in overseeing all aspects of the study, including external vendors, and coordinating with Regulatory, Commercial, Legal, Finance, and other departments within Impulse Dynamics. In this way, the department serves as a cross-functional liaison and creates a positive, collaborative team environment with an eye toward innovation and operational excellence. You will be joining a team that is committed to meaningfully advancing the science of heart failure treatment for a global community of patients and their healthcare providers.
Reporting to the Senior Clinical Trial Manager, the Associate CTM manages all clinical trial activities and workstreams across assigned clinical trial(s). The Associate CTM, under guidance of Clinical and Medical leadership, coordinates day-to-day execution, tracks milestones and risks, oversees assigned site and vendor activities, and escalates issues that may affect study quality, timelines or budget.
The Associate CTM will manage the assigned clinical trial(s) in adherence to Good Clinical Practices (ICH/GCPs) and in compliance with appropriate company Standard Operating Procedures (SOPs) as applicable under the regulatory agency(ies) governing the study, and any other applicable guidelines and regulations.
The Associate CTM is responsible for independently managing a range of activities for multi-center, medical device clinical studies in the US and/or OUS. The position requires strong leadership skills and the ability to coordinate cross-functional teams, meet project goals and timelines, and be aligned with company initiatives.
How You’ll Add Value
- Write or contribute to the preparation of clinical protocols, amendments, informed consent forms, case report forms, monitoring plans, data management plans, and any other clinical research related documents.
- Proactively coordinate, manage, and oversee the various project level operational aspects including management of trial timeline, budget, resources, and vendors.
- Provide regular updates on trial progress to clinical leadership with respect to vendor selection, project plans, trial budget and timeline management, and risk mitigation.
- Lead study startup processes, including but not limited to site selection and finalization of clinical trial agreements and budgets.
- Ensure effective project plans are in place and work proactively with clinical trial team to set priorities in accordance with applicable project plans, company SOPs, ICG/GCP guidelines, and regulatory requirements.
- Manage day-to-day clinical trial operations for assigned studies from study start-up throughout closeout.
- Ensure potential study risks are escalated to the attention of clinical leadership when appropriate.
- Ensure tracking, follow-up, and resolution of site monitoring issues in a timely manner.
- Monitor the quality of vendor deliverables, address quality issues with the appropriate team member, 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.
- Participate in investigator meetings and study team meetings.
- Support inspection and audit readiness activities and assist in addressing audit findings when necessary.
- Maintain accurate study records and documentation within the Trial Master File (TMF).
What You’re Bringing with You
- Bachelor’s degree or higher, in a scientific, clinical, or related field
- Minimum of 2 years of progressive experience in clinical operations, clinical trial management, or project management within the pharmaceutical, biotechnology, medical device, or contract research organization (CRO) industries. Experience supporting multicenter clinical studies preferred.
- 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.
- Preferred: Prior experience in heart failure and/or cardiac rhythm management clinical studies is strongly preferred. Experience managing CROs and external vendors.
Compensation & Benefits
Annual Base Salary Range: $ 110,000 - 130,000
Annual Base Salary Range: $ 110,000 - 130,000
- 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
Unless specifically indicated communicated otherwise in writing, all employees are “at-will” employees. The Company reserves the right to modify the aforementioned terms with appropriate notice and under no circumstance do the above described compensation and benefits constitute a promise to continue them for the duration of an employee’s employment.
Our commitment to you
Our hiring process lets you show off the very best version of yourself while learning all about us at the same time. Our recruiting promise is a candidate experience that’s enjoyable, thorough, and fair. That’s our way of inspiring the innovative brightest minds.
Impulse Dynamics has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere—we strive to foster an inclusive culture built around the diversity of thought and mutual respect. We lead with inclusion and empower our team members to do their best work as their most authentic selves. We strive to foster an inclusive and diverse team, committed to making a difference.
Equal Opportunity Employer Statement:
Impulse Dynamics is an equal opportunity employer.
Impulse Dynamics is committed to the spirit and letter of all federal, state, and local laws and regulations pertaining to equal opportunity. To provide equal employment and advancement opportunities to all applicants, employment decisions at the company will be based on merit, qualifications, and abilities. The company does not unlawfully discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or other protected status. This policy extends to all terms, conditions, and privileges of employment, as well as the use of all Impulse Dynamics facilities.