Bachelor's degree in a relevant scientific discipline or equivalent
7+ years of relevant experience, including 2+ years in a CRA role within the medical device industry
Preferred regulatory experience in the medical device sector
Knowledge of medical device regulatory requirements
Ability to work independently with general instructions
Strong cross-functional teamwork skills
Proficient in multi-tasking and prioritizing high-priority projects
Responsibilities
Lead operational execution of clinical studies
Manage site operations for pre- and post-market studies
Assist in developing protocols, informed consents, and monitoring plans
Conduct monitoring visits in compliance with regulations and guidelines
Coordinate investigator meetings and serve as a liaison for CTA negotiations
Train clinical site staff to ensure compliance and data quality
Oversee internal and external CRA teams, ensuring clear communication
Benefits
Partially remote work option (up to two days a week)
Travel opportunities within the USA (up to 50%)
Engagement in diverse clinical studies
Collaboration with cross-functional teams
Professional development opportunities in clinical research
Full Job Description
The Clinical Research Manager is a full-time position. This position 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
