Clinical Manager

Endovascular Engineering•Menlo Park, CA

4d•$150,000 - $170,000•Hybrid

About The Position

Endovascular Engineering is a medical device start-up developing technology for cardiovascular critical care and mechanical thrombectomy. The Clinical Research Manager leads operational execution and site management for pre- and post-market clinical studies. The role can be partially remote up to two days a week and requires some travel within the USA, up to 50%.

Requirements

Bachelor’s degree in a relevant scientific discipline or equivalent.
At least 7 years of relevant experience, including at least 2 years in a CRA functional role in the medical device industry.
Knowledge of relevant medical device regulatory requirements.
Able to perform assignments with general instructions.
Ability to multi-task and prioritize multiple high-priority projects, site questions, and clinical team inquiries while managing responsibilities and deadlines.
Functional and technical knowledge and skills to perform the job at a high level of accomplishment.

Nice To Haves

Regulatory experience in the medical device industry is preferred but not required.
Ability to work effectively on a cross-functional team is desired.

Responsibilities

Lead operational execution of clinical studies.
Manage sites for pre- and post-market studies to support successful clinical programs and cross-functional strategies.
Assist with or lead development of protocols, informed consents, case report forms, monitoring plans, and clinical study reports.
Conduct monitoring visits in compliance with study monitoring plans, SOPs, GCP, and applicable government regulations and guidelines.
Coordinate and/or participate in investigator meetings.
Serve as a liaison for clinical trial agreement and budget negotiations.
Manage study sites and train site staff to ensure protocol and regulatory compliance and data quality.
Manage internal CRA team members.
Oversee external CRAs and provide direction on the clinical protocol and trial support.
Assist with projection and management of clinical supplies.
Track clinical data, regulatory documents, patient enrollment, and data resolutions.
Track study budgets, milestones, and deadlines; update study timelines and metrics.
Prepare for and conduct site qualification, study initiation, interim monitoring, and close-out visits as needed.
Review listings and resolve queries during database lock and in preparation for final study reports.
Maintain the study master file in compliance with internal procedures and applicable country-specific regulations.
Participate in study audits as applicable.