Clinical Trial Manager

ontribute to the organization.

Essential Duties and Responsibilities:
• Contribute to content generation, writing and editing of study protocols, amendments, informed consents, committee charters, study reports, monitoring plans, and other related clinical and regulatory documents.
• Assist with the management of investigational studies from study start through study closure.
• Engage in a new study trial design with cross functional teams, including clinical and pre-clinical research and development groups.
• Responsible for ensuring the clinical portion of the study is always inspection ready.
• Update and design study dashboards, study trackers, and other applicable study documents to provide regular updates on trial status.
• Manage the development of clinical trial plans, monitoring strategies, and risk mitigation strategies.
• Contribute to the development and maintenance of Case Report Forms (CRFs).
• Assist with the formulation of instructional materials and the training of investigators, study coordinators, and associated study site personnel on study related activities and the conduct of the clinical trials, as applicable.
• Assist with safety monitoring, including the preparation of supporting documents for CEC and/or DSMB, meetings, agenda, data review, presentations, and updating relevant trackers as applicable.
• Manage the tracking of patient enrollment and site payments.
• Serve as the main point of contact between CRO personnel and MiRus.
• Oversee site selection, activation, and monitoring activities to ensure ongoing compliance of study protocols in accordance with applicable regulations, ICH/GCP guidelines, and MiRus SOPs.
• Oversee the collection, review, and maintenance of study documents and management of the Trial Master File (TMF).
• Oversee and support the field study monitors and external vendors, including CROs.
• Serve as CRA’s point of contact for site issues and escalations.
• Provide continuous data review of source documents, case report forms, and data reports as appropriate.
• Review monitoring trip reports, protocol deviations, safety reports, and action items.
• Oversee the tracking and uploading of study imaging.
• Interact with cross functional teams, as applicable.
• Support applications and technical files as needed.
• Assist with preparation of investigator meetings.
• Perform additional clinical operations tasks as required.

Minimum Education and/or Experience:
• Bachelor’s or Master’s degree in life science, health science, or a related field with clinical experience in the cardiac field (CCU, CVOR, Cath Lab) and experience in a clinical research role.
• At least 2 years of experience in clinical research role, preferably in cardiovascular medical device.
• Experience in clinical trials and/or post-market registries in the U.S., Australian and/or European Union, with other geographies desired.
• Current knowledge of medical device clinical trials design and best practices.
• Proficient knowledge of FDA regulations and ICH/GCP guidelines, guidance documents, and other applicable regulations and standards, and implementation of these standards in the medical device industry, in the U.S. and all countries in which trials are conducted.
• General application of medical terminology (cardiovascular specific preferred).

Benefits:

MiRus offers competitive compensation, options, full benefits, and relocation assistance.

· 401(k)

· Dental insurance

· Vision insurance

· Disability insurance

· Employee assistance program

· Flexible spending account or Health Savings Account

· Health insurance

· Life insurance

· Paid time off

Schedule:

· Monday to Friday (8am – 5pm)

Work Location:

· Onsite

· Position may require domestic travel at least 5%