Endovascular Engineering is an exciting medical device start-up company dedicated to developing innovative technology for cardiovascular critical care. This is an exciting opportunity to join an enthusiastic and talented team of professionals working to establish a new standard in mechanical thrombectomy. The Clinical Research Manager is a full-time position. This position is based on-site in Menlo Park, California, and can be partially remote up to two days a week. Some travel within the USA will be required (up to 50%).
Responsibilities
- Lead operational execution of clinical studies
- Maintain responsibility for site management for pre- and post-market studies ensuring successful conduct of clinical programs, and cross- functional strategies
- May assist in or be responsible for development of protocols, informed consents, case report forms, monitoring plans, and clinical study reports
- Conduct monitoring visits in compliance with the study specific Monitoring Plan, Standard Operating Procedures, Good Clinical Practices (GCP) and applicable government regulations and guidelines
- Coordinate and/or participate in investigator meetings
- Serve as a liaison for clinical trial agreement (CTA) and budget negotiations
- Manage study sites and train the clinical site staff to ensure protocol and regulatory compliance and quality of data
- Manage internal CRA team member(s)
- Oversee external CRAs, providing clear communication and direction with regards to the clinical protocol and general trial support
- Assist with projection and management of clinical supplies
- Track clinical data, regulatory documents, patient enrollment, and data resolutions
- Track progress of clinical studies with regards to budget, study milestones, and deadlines
- Responsible for updating study timelines and metrics
- Prepare for and execute site qualification, study initiation, interim monitoring, and close-out visits at clinical sites as necessary to ensure study requirements are being fulfilled
- Responsible for listing review and resolution of queries during database lock and in preparation of final study reports
- Ensure maintenance of study master file to ensure compliance with internal procedures, and applicable country-specific regulations
- Participate in study audits, as applicable
Qualifications
- Bachelor’s degree in a relevant scientific discipline or equivalent
- At least 7 years of relevant experience with at least 2 years in a CRA functional role in the medical device industry.
- Regulatory experience in the medical device industry is preferred but not required.
- Knowledge of relevant medical device regulatory requirements
- Able to perform assignments with general instructions
- Ability to work effectively on a cross-functional team is desired
- Ability to multi-task and prioritize multiple high-priority projects, site questions, and clinical team inquiries while managing responsibilities and deadlines
- Must have the functional and technical knowledge and skills to do the job at a high level of accomplishment
