Senior Clinical Study Manager

Intuitive•Sunnyvale, CA

About The Position

The Senior Clinical Study Manager develops and executes strategies for clinical and outcomes research studies supporting regulatory approvals and strategic evidence initiatives. As a member of Clinical Affairs, this role works with stakeholders to design protocols and conduct pre-market and post-market clinical studies with minimal supervision. The manager collaborates with CRAs, CTAs, data management, biostatisticians, investigators, and other internal and external partners to carry out studies, interpret results, prepare study reports, and support scientific publications. The role drives study progress from site selection and start-up through enrollment and follow-up, provides guidance to monitors, oversees study compliance, and leads communications with investigators and study teams. It also contributes scientific and literature reviews, clinical strategy, regulatory submissions, process improvement, and post-market research activities. The position requires travel of 25–40%, or as business needs require.

Requirements

Previous experience implementing, supporting, and managing medical device trials.
Significant knowledge of clinical and/or outcomes research study design.
Strong experience developing protocols and informed consent forms and writing clinical sections for regulatory submissions.
Strong experience conducting literature searches, reviews, and appraisals of scientific data.
Ability to interact effectively with physicians and other professionals inside and outside the company.
Knowledge of ICH/GCP and other applicable regulations, and a fundamental understanding of clinical research and monitoring requirements.
Experience negotiating clinical research contracts and budgets.
Ability to work effectively on cross-functional teams.
Ability to travel 25–40%, or as business requirements dictate.
Ability to manage multiple projects and balance competing priorities.
Strong communication, presentation, and interpersonal skills, with attention to detail and organization.
Ability to learn quickly, adapt to changing requirements, and self-educate on surgical specialties relevant to clinical projects.
Self-starter attitude and problem-solving mindset, including willingness to support aggressive timelines or multiple projects when necessary.
Advanced degree (M.S., Ph.D., or M.D.) in a scientific or bioengineering field and at least 5 years of clinical research experience; or a bachelor's degree in a scientific or bioengineering field and at least 8 years of clinical research experience; or at least 10 years of clinical research experience combined with relevant scientific or technical training.

Nice To Haves

Comfort working in a hospital environment; experience working with nurses and surgeons is preferred.
Understanding of statistics, statistical methods, and experimental design.
Extensive experience independently managing pre-market clinical studies, including First Human Use or IDE studies used for regulatory submissions.
Strong track record of KOL management for multi-center studies.
Experience working on global or multinational studies.

Responsibilities

Lead assigned clinical research activities.
Collaborate with internal stakeholders, investigators, and KOLs to develop and review study designs and concepts, prepare protocols and study outlines, and drive research initiatives.
Plan and execute clinical studies, including site selection, patient recruitment analysis and projections, preparation of study documents, and coordination of IRB/EC submissions and follow-up.
Independently conduct clinical studies on schedule and within budget while maintaining quality and compliance.
Conduct on-site and remote site qualification, initiation, interim monitoring, and close-out visits.
Monitor studies for regulatory and protocol compliance and data accuracy in accordance with the clinical monitoring plan.
Perform source data verification of study data in EDC systems, case report forms, or data listings.
Liaise with study sites and support internal audits and inspections, maintaining sponsor audit readiness.
Negotiate vendor and site contracts and budgets in collaboration with legal and management teams.
Track study progress and provide regular status reports.
Work with biostatisticians on data analysis, interpretation, and synthesis to develop clinical study reports and support scientific publications.
Track, process, and manage site payments and support study financial tracking.
Organize and lead study meetings and other study activities.
Mentor junior clinical study managers and guide CRAs and CTAs on monitoring and other study needs.
Follow corporate SOPs and applicable regulatory requirements, including GCP and U.S. and OUS guidelines, and proactively manage studies accordingly.
Conduct literature searches and stay current with relevant scientific and clinical knowledge and evidence gaps.
Critically appraise scientific literature and write clinical summaries to support research, clinical strategies, and investigational protocols.
Review and revise Clinical Operations SOPs in support of continuous process improvement.
For post-market research, collaborate with commercial groups to understand market trends and support business goals through Clinical Affairs activities.
For post-market research, provide scientific expertise to Health Economics and Outcomes Research, including identifying diagnosis or reimbursement codes and selecting clinical outcomes.
Work with investigators to prepare manuscripts, abstracts, slide presentations, and posters for scientific meetings and publications.
Support regulatory submissions and approvals for pre-market clinical studies and 510(k) submissions, including responses to regulatory body questions about study design and results.
Lead project teams consisting of CRAs and CTAs and provide management with relevant study updates.