Senior Clinical Study Manager

This is a fully remote position, open to applicants in California.

📋 Description

• Formulate and implement strategies for clinical and outcomes research studies that support regulatory approvals and strategic evidence initiatives.

• Create and develop clinical protocols and conduct pre-market or post-market clinical studies with minimal oversight.

• Collaborate with Clinical Research Associates (CRAs), Clinical Trial Assistants (CTAs), data management teams, biostatisticians, investigators, key opinion leaders (KOLs), and internal stakeholders.

• Plan and carry out studies, which includes site selection, patient recruitment projections, site initiation, enrollment, and follow-up.

• Develop protocols, case report forms, informed consent documents, clinical trial agreements, and study reports.

• Organize submissions to Institutional Review Boards (IRB) or Ethics Committees (EC) and ensure continuous study progress.

• Conduct site qualification, initiation, interim monitoring, and close-out visits, both on-site and remotely.

• Oversee studies for compliance with regulatory standards and protocol as well as data accuracy.

• Complete source data verification in Electronic Data Capture (EDC) systems, case report forms, or data listings.

• Assist with internal audits, inspections, and preparation for sponsor audits.

• Negotiate contracts and budgets with external vendors and sites, collaborating with legal and management teams.

• Monitor study progress, provide status updates, and manage site payments and financial tracking for the study.

• Work alongside biostatisticians for data analysis, interpretation, and synthesis for clinical study reports and scientific publications.

• Organize study meetings and provide mentorship to junior clinical study managers.

• Offer guidance to CRAs and CTAs.

• Adhere to corporate Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and both U.S. and international regulatory guidelines.

• Perform literature searches, critically evaluate scientific literature, and compose clinical summaries.

• Review and enhance Clinical Operations SOPs for process improvement.

• Collaborate with commercial teams on post-market research, providing scientific expertise to Health Economics and Outcomes Research.

• Partner with investigators to prepare manuscripts, abstracts, slide presentations, and posters.

• Assist with regulatory submissions and approvals for pre-market studies and 510(k)s, including responding to regulatory inquiries.

⛳️ Requirements

• Prior experience in implementing, assisting, and managing medical device trials.

• Extensive knowledge of clinical and/or outcomes research study design.

• Proven track record in protocol and informed consent form (ICF) development and writing clinical sections for regulatory submissions.

• Demonstrated experience in conducting literature searches, reviews, and appraisal of scientific data.

• Familiarity with Good Clinical Practice (ICH/GCP) and other relevant regulations.

• Basic understanding of clinical research and monitoring requirements.

• Experience in negotiating clinical research contracts and budgets.

• Ability to collaborate effectively in cross-functional teams.

• Willingness to travel 25–40% or as business needs dictate.

• Capability to manage multiple projects and adapt to changing priorities.

• Excellent communication, presentation, and interpersonal skills with a strong attention to detail and organization.

• Ability to quickly learn, adapt to changing requirements, and self-educate on surgical specialties.

• Capacity to lead project teams comprising CRAs and CTAs.

• Strong work ethic and a problem-solving approach.

• Minimum of an advanced degree in a scientific or bioengineering field (M.S., Ph.D., or M.D.) with 5 years of clinical research experience, or a bachelor’s degree in a scientific or bioengineering field with 8 years of clinical research experience, or 10 years of clinical research experience with relevant training.

• Preferred experience working in a hospital setting and with nurses and surgeons.

• Preferred knowledge of statistics, statistical methods, and experimental design.

• Current proof of vaccination against certain diseases, including COVID-19, may be required.

• Candidates must comply with applicable U.S. export-control regulations where necessary.

🏝️ Benefits

• Opportunity for remote work; employees are expected to come onsite when requested by leadership.

• Incentives.

• Comprehensive benefits.

• Equity options.

• Reasonable accommodations for qualified individuals with disabilities.

• Potential vaccination requirements, including COVID-19 vaccination, depending on the role or customer specifications.