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Clinical Trial Manager

Impulse Dynamics

New Jersey

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JOB DETAILS
SKILLS
Biotech and Pharmaceutical, Budget Management, Budgeting, Cardiac Monitoring, Cardiology, Case Report Form (CRF), Clinical Best Practices, Clinical Information Systems, Clinical Monitoring, Clinical Practices/Protocols, Clinical Research, Clinical Support, Clinical Trial, Clinical Trial Management, Communication Skills, Compensation and Benefits, Congestive Heart Failure, Contract Research Organization (CRO), Corporate Compliance, Cross-Functional, Data Management, Drug Development, Establish Priorities, FDA Requirements, Finance, GCP (Good Clinical Practices), Healthcare Providers, ICH Regulations, IDE (Integrated Development Environment), Informed Consent, Interpersonal Skills, Leadership, Legal, Medical Equipment, Microsoft Office, Multitasking, Operations Processes, People Management, Presentation/Verbal Skills, Problem Solving Skills, Progress Reports, Project Planning, Project Tracking, Project/Program Management, Quality Control, Quality Monitoring, Regulations, Regulatory Compliance, Regulatory Requirements, Reporting Skills, Risk Management, Standard Operating Procedures (SOP), Startup, Team Player, Time Management, Vendor/Supplier Selection, Writing Skills
LOCATION
New Jersey
POSTED
2 days ago
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 CTM is responsible for the management of all aspects of the clinical trial team activities for the assigned clinical trial(s). The CTM, together with Clinical and Medical leadership, is responsible for clinical operational oversight and execution (initiation, enrollment, and completion) of complex medical device clinical trials.

The 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 CTM is responsible for independently managing a range of activities for multi-center, single-arm, medical device clinical studies in the US. This position requires strong leadership skills and the ability to manage people, meet clinical project goals and timelines, and be in alignment 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 of the CTT 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 conduct of the clinical trial Investigator meeting together with clinical and medical leadership, site selection, and finalization of site clinical trial site agreements and budgets.
  • Ensure effective project plans are in place and operational and work proactively with the CTT to set priorities in accordance with applicable project plans, company standard operational procedures (SOPs), ICH/GCP guidelines, and regulatory requirements.
  • Ensure potential study risks are escalated to the attention of clinical leadership when appropriate.
  • Lead the CTT working group and vendor status update meetings.
  • 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.
What You’re Bringing with You
  • 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 contract research organization (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 contract research organization 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.
  • 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: $ 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

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.

 

About the Company

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Impulse Dynamics