Enchannel Medical is redefining the boundaries of electrophysiology with our next-generation DePolar™ mapping system and integrated NanoAblate™ PFA platform. Driven by our global mission to enhance the quality-of-life of cardiac arrhythmia patients, our discerning technology, paired with our passion for innovation, leads to enduring outcomes.

Position Overview

The Clinical Trial Manager will oversee the planning, execution, and management of clinical studies to ensure compliance with protocols, ICH/GCP guidelines, and company standards. Responsibilities include managing timelines, budgets, vendors, and study documentation; coordinating cross-functional and site activities; and ensuring audit readiness and quality throughout the trial lifecycle.

Duties and Responsibilities   

The following are the major responsibilities needed for the role.  Additional responsibilities, tasks, and duties will be assigned and required as needed.

• Manages all clinical aspects of study under oversight of Clinical Operations management including but not limited to initial operational feasibility, study timelines, budget and metrics; study document development and review (training documentation, ICF, study specific plans, eCRF Guidelines, lab and radiology manuals, etc.), plans and manages study-specific meetings (e.g. Study Team Meetings, Investigator meetings, etc.).
• Ensures clinical trials are executed in compliance with the protocol and ICH/GCP guidelines/regulations including but not limited to participate in the planning of quality assurance activities and coordinate resolution of audit findings; ensure audit-ready condition of clinical trial documentation; review monitoring reports to ensure quality and resolution of site-related issues. 
• Execute clinical monitoring, site initiation visits and close out visits in adherence to ISO14155, Good Clinical Practices (GCPs) and ensure studies are in compliance with study protocol, appropriate Standard Operating Procedures (SOPs), and ICH/GCP regulations and study-specific manuals and procedures and write/revise the relevant reports, as necessary
• Work with QA for CAPA documentation and resolution.
• Manages the study submission to IRB/ECs in coordination with CRO, as appropriate.
• Assist selection activities for external vendors and is responsible for the management/oversight of external vendors including but not limited to the development vendor specifications, review vendor reports, budgets, and metrics
• Provides study-specific training and delivers Sponsor’s guidance to clinical research staff, including CRO, CRAs, sites and other contract personnel
• Conducts the internal review of investigator contracts and payments, as necessary.
• Prepares and presents project debriefings to Clinical Operations management.
• Uses operational and therapeutic expertise to optimize trial design and execution and works with the study team to strategize clinical trial execution.
• Works with the CRO and facilitate Sponsor clinical lead to select and approve sites and manages start-up processes toward activating sites; develops relationships with investigators and site staff.
• Interfaces with cross-functional teams (e.g. Medical Monitor, Regulatory Affairs, CMC/Supply Chain, CRO, vendors and Investigators/site staff). Works cross-functionally and with external vendors to proactively manage the execution of the clinical trial.
• Oversea TMF management and review TMF document as necessary

 Education, Experience and Skills Required

Below are the minimum skills, formal education, certifications or training, and practical experience required to perform the general functions and duties of the role. 

• Bachelor’s degree or higher in science or health related field; preferably biotechnology, pharmaceutical or CRO industry.
• Minimum of 4 years of clinical trial management
• Minimum of 2 years as clinical research associate with on-site/remote clinical monitoring
• Global registration study experience a plus
• Robust understanding of ICH/GCP and regulatory requirements
• Strong clinical study/project management skills
• Deep knowledge of FDA regulations and willingness to learn foreign regulatory requirements
• Excellent communication, written and organizational skills; along with problem solving, conflict resolution, leadership and team-building skills.
• Ability to motivate and collaborate with cross functional teams.
• Ability to work independently, take initiative, and meet company goals within timelines and budget
• Able to work in a fast-paced environment with multiple competing tasks and priorities, across time-zones
• Ability to communicate with vendors and keep a high quality of clinical study
• Proficient in Microsoft Office (Excel, Word, Outlook, PowerPoint), electronic data capture (EDC) software (Medidata and others) and other platform related to electronic Trial Master File (eTMF) and safety report 

Our pay ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum new hire pay for the position located in California. Within the range, individual pay is determined by location, additional factors, including job-related skills, experience, and relevant education or training. 

EnChannel Medical is an E-Verify and equal opportunity employer. We believe in hiring a diverse workforce and sustaining an inclusive, people-first culture. We are committed to non-discrimination on any protected basis, such as disability and veteran status, or any basis covered under acceptable law.

Only qualified candidates will be contacted. 

JOB CODE: 1374