Senior Clinical Study Manager

Intuitive•Sunnyvale, CA

22h•$128,900 - $218,300•Onsite

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 part of the Clinical Affairs team, the role works with stakeholders to design protocols and conduct pre-market or post-market studies with minimal supervision. The manager collaborates with CRAs, CTAs, data management, biostatisticians, investigators, and study teams to advance study execution, analyze and interpret results, prepare study reports, and support scientific publications. The role drives studies through site selection, start-up, enrollment, and follow-up; provides guidance on monitoring needs; oversees compliance; and leads external communications with investigators and study teams. It also contributes clinical literature reviews and evidence strategy, regulatory submissions, operational process improvements, financial tracking, and post-market research aligned with business goals. The position may require travel of 25–40% or as business needs dictate and is Purposeful Onsite, requiring attendance at leader-defined onsite events and activities, potentially with increased frequency based on business need.

Requirements

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.
Excellent ability to interact with physicians and other professionals inside and outside the company.
Knowledge of ICH/GCP and other applicable regulations, and 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 high attention to detail and organization.
Ability to learn quickly, adapt to changing requirements, and self-educate on surgical specialties relevant to clinical projects.
Ability to lead project teams consisting of CRAs and CTAs and provide management with relevant study updates.
Strong work ethic, problem-solving mindset, and ability to meet aggressive timelines or manage multiple projects when necessary.
One of the following: an advanced degree (M.S., Ph.D., or M.D.) in a scientific or bioengineering field and at least 5 years of clinical research experience; 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 in a hospital environment and experience working with nurses and surgeons.
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 key opinion leader management for multi-center studies.
Experience working on global or multinational studies.

Responsibilities

Lead assigned clinical research activities.
Collaborate with internal stakeholders, investigators, and key opinion leaders to develop and review study designs and concepts, prepare protocols and study outlines, and drive identified initiatives.
Plan and execute clinical studies, including site selection, patient recruitment analysis and projections, study document creation, and IRB/EC submissions and follow-through.
Independently conduct clinical studies on schedule and within budget while ensuring quality and compliance.
Perform site qualification, site initiation, interim monitoring, and site close-out visits, both onsite and remotely.
Monitor studies for regulatory and protocol compliance and data accuracy according to the clinical monitoring plan.
Complete source data verification of study data in EDC systems, case report forms, or data listings.
Liaise with sites and support internal audits and inspections, maintaining sponsor audit readiness.
Negotiate contracts and budgets with external vendors and sites in collaboration with legal and management.
Track study progress and provide regular status reports.
Work with biostatisticians on data analysis, interpretation, and synthesis, and develop study reports or support scientific publications.
Track, process, and manage site payments and support study financial tracking.
Organize and lead study meetings and other assigned 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 informed about relevant scientific and clinical knowledge and evidence gaps.
Critically appraise scientific literature and write clinical summaries to inform research and clinical strategies and protocols.
Review and revise Clinical Operations SOPs to support continuous process improvement.
For post-market research, collaborate with commercial groups to understand market trends and support business goals through Clinical Affairs activities.
Provide scientific expertise to Health Economics and Outcomes Research on outcomes analyses, including diagnosis or reimbursement codes and clinical outcomes selection.
Work with investigators to prepare manuscripts, abstracts, slide presentations, and posters for scientific meetings and publications.
Support regulatory submissions and approvals for pre-market studies and 510(k) submissions, including responses to regulatory-body questions about study design and results.