Senior Clinical Study Manager

Intuitive•Sunnyvale, CA

2d•$128,900 - $218,300•Remote

About The Position

The Senior Clinical Study Manager (Clinical Study Manager-4) develops and executes strategies for clinical and outcomes research studies that support regulatory approvals and strategic evidence initiatives. As a member of the Clinical Affairs team, the role works with stakeholders to design and develop protocols and conduct pre-market and post-market clinical studies with minimal supervision. The manager coordinates closely with clinical research associates, clinical trial assistants, data management, and biostatisticians to conduct studies, interpret results, prepare study reports, and support scientific publications. The role leads study progress from site selection and start-up through enrollment, follow-up, and closeout, providing direction on monitoring needs and overseeing study compliance. It also includes literature research and appraisal, development of clinical strategies and protocols, support for regulatory submissions, and collaboration with investigators, vendors, commercial teams, and Health Economics and Outcomes Research. The position is remote, with employees expected to come onsite when requested by their leader, and requires travel of 25–40% or as business needs require.

Requirements

Experience implementing, supporting, and managing medical device trials.
Significant knowledge of clinical and/or outcomes research study design.
Proven experience developing protocols and informed consent forms and writing clinical sections for regulatory submissions.
Proven experience conducting literature searches, reviews, and scientific data appraisal.
Ability to interact effectively with physicians and other professionals inside and outside the company.
Knowledge of ICH/GCP and other applicable regulations, and fundamental knowledge 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 required by business needs.
Ability to manage multiple projects and competing priorities.
Strong communication, presentation, and relationship skills, with attention to detail and organization.
Ability to learn quickly, adapt to changing requirements, and independently learn about surgical specialties relevant to clinical projects.
Ability to drive project teams consisting of CRAs and CTAs and provide management with relevant study updates.
Strong work ethic, problem-solving mindset, and ability to help meet tight timelines or manage multiple projects when necessary.
Advanced degree in a scientific or bioengineering field (M.S., Ph.D., or M.D.) 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 with relevant training.

Nice To Haves

Experience working in a hospital environment and with nurses and surgeons.
Knowledge of statistics, statistical methods, and design of experiments.

Responsibilities

Lead assigned clinical research activities.
Partner 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 review and projections, preparation of study documents, and coordination and follow-through of IRB/EC submissions.
Conduct studies autonomously on schedule and within budget while ensuring quality and compliance.
Perform site qualification, initiation, interim monitoring, and closeout visits, both onsite and remotely.
Monitor studies for regulatory and protocol compliance and data accuracy according to the clinical monitoring plan.
Perform source data verification of study data in electronic data capture systems, case report forms, or data listings.
Liaise with sites and support internal audits and inspections to ensure sponsor audit readiness.
Negotiate vendor and site contracts and budgets in partnership with the legal team and management.
Track study progress and provide regular status reports.
Work with biostatisticians on data analysis, interpretation, and synthesis for study reports and scientific publications.
Track and process site payments and support study financial tracking, developing tracking tools as needed.
Organize and lead study meetings and other assigned study activities.
Mentor junior clinical study managers and guide CRAs and CTAs on monitoring and 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 remain informed about 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 to support continuous process improvement.
For post-market research, partner 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 diagnosis or reimbursement code identification and clinical outcome selection.
Work with clinical investigators to prepare manuscripts, abstracts, slide presentations, and posters for scientific meetings and publications.
Support regulatory submission and approval of pre-market clinical studies and 510(k) submissions, including addressing regulatory body questions about study design and results.