Manager, Clinical Research

Position Summary:

The Manager, Clinical Research reports to the Director, Clinical Research and is responsible for leading and managing clinical research activities with participating study physicians and research sites. This role serves as the primary point of contact for the organization and execution of pre- and post-market clinical studies, ensuring studies are conducted in compliance with Good Clinical Practice (GCP), FDA regulations, and applicable clinical research standards.

The Manager collaborates cross-functionally with Clinical, Regulatory, R&D, Marketing, and external investigators to support study integrity, patient safety, and accurate data collection and documentation. This individual is responsible for study oversight from start-up through close-out, including monitoring activities, study documentation, data management, and site support.

Duties & Responsibilities:

• Lead the development and management of clinical study documentation, including protocols, case report forms (paper and electronic), informed consent forms, subject questionnaires, clinical study reports, statistical analysis plans, and regulatory submissions.
• Coordinate and conduct site qualification, study initiation, interim monitoring, training, and close-out visits, ensuring timely completion of accurate monitoring reports.
• Serve as the primary liaison between study sites, investigators, clinical coordinators, and internal stakeholders.
• Monitor clinical study data remotely and on-site with a focus on data integrity, protocol compliance, and patient safety.
• Develop, maintain, and manage clinical databases, study tracking tools, and study metrics reporting.
• Track study documentation and case report forms to ensure timely and accurate data flow and study execution.
• Generate, manage, and resolve data queries in collaboration with study sites.
• Prepare and maintain sponsor and site regulatory documentation, including Trial Master Files (TMF/eTMF) and essential study records.
• Assist with IRB submissions, ClinicalTrials.gov postings, and other regulatory reporting activities.
• Analyze clinical data and prepare study performance, progress, and data analysis reports.
• Develop work instructions, study-specific procedures, and data capture guidelines to support standardized study execution.
• Evaluate clinical research processes, systems, and technologies to improve operational efficiency and compliance.
• Support software selection and implementation for clinical research activities as needed.
• Train internal staff and study personnel on study procedures, photography standards, and clinical software systems.
• Provide clinical research support to cross-functional teams including Clinical Affairs, Regulatory, R&D, and Marketing.
• Ensure all study activities are conducted in accordance with company SOPs, FDA regulations, ICH-GCP guidelines, and other applicable regulations.
• Other duties as needed or required.

Minimum Requirements & Qualifications:

• Bachelor's degree in Life Sciences, Allied Health, or related medical/scientific field, or equivalent combination of education and experience.
• Minimum of 5 years of clinical research experience, including 1-2 years as a Lead, Supervisor, or Manager, preferably within the medical device, dermatology, or aesthetic industry.
• Demonstrated experience independently managing clinical studies from start-up through close-out.
• Strong knowledge of FDA regulations, ICH-GCP guidelines, medical terminology, and clinical trial processes.
• Experience with EDC, eTMF, and clinical data management systems preferred.
• Experience participating in FDA Bioresearch Monitoring (BIMO) audits preferred.
• Proficient with Microsoft Office applications including Word, Excel, and PowerPoint.
• Strong analytical, organizational, and problem-solving skills with exceptional attention to detail.
• Excellent verbal and written communication and interpersonal skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Self-motivated, collaborative, and able to work independently.
• Must be willing to work on-site at the corporate headquarters in Brisbane, CA.
• Ability to travel up to 30% as needed.