Sr. Clinical Study Manager

Overview

5 days ago Be among the first 25 applicants

This range is provided by Intuitive. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

$/yr - $/yr

At Intuitive, we are united behind our mission: we believe that minimally invasive care is life-enhancing care. Through ingenuity and intelligent technology, we expand the potential of physicians to heal without constraints. As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference. For more than 25 years, we have worked with hospitals and care teams around the world to help solve some of healthcare s hardest challenges and advance what is possible.

Intuitive has been built by the efforts of great people from diverse backgrounds. We believe great ideas can come from anywhere. We strive to foster an inclusive culture built around diversity of thought and mutual respect. We We lead with inclusion and empower our team members to do their best work as their most authentic selves. Passionate people who want to make a difference drive our culture.

Our team members are grounded in integrity, have a strong capacity to learn, the energy to get things done, and bring diverse, real world experiences to help us think in new ways. We actively invest in our team members to support their long-term growth so they can continue to advance our mission and achieve their highest potential. Join a team committed to taking big leaps forward for a global community of healthcare professionals and their patients.

Together, let s advance the world of minimally invasive care.

Primary Function of the Position

This position requires a candidate with extensive experience helping evidence generation strategy and execution of clinical studies. The Clinical Study Manager-4 (CSM IV) role will develop and execute strategies for clinical and outcomes research studies to help regulatory approvals and key strategic evidence initiatives. As a member of the Clinical Affairs team, this role will be accountable for working with key stakeholders to design and develop clinical protocols and execute clinical studies (pre-market or post-market studies), with minimal supervision.

The candidate will be required to work closely with clinical research associates (CRAs), clinical trial assistants (CTAs) and data management for the conduct and execution of the study, as well as with biostatisticians to review and interpret results of clinical studies, develop clinical study reports, or help the development of clinical publications. During trial execution, the CSM will drive the progress of the trial during site selection, site start-up and through enrollment and follow-up.

The CSM will clearly provide guidance to the monitors about monitoring needs, and oversee compliance work on the study. The CSM will also take a leadership role in external communication with investigators and study teams. The ideal candidate will have experience previously managing premarket studies in the United States and utilizing resources to research and scope research topics and to provide recommendations on clinical trial strategy.

The candidate is also expected to have experience reviewing, interpreting and summarizing clinical literature.

Essential Job Duties

• Accountable for leading assigned clinical research activities
• Partner with internal stakeholders, investigators and KOLs to develop and review study design and concepts, prepare protocol and study outlines and subsequently driving identified initiatives
• Accountable for the planning and execution of the clinical studies including site selection, review of potential patient recruitment and projections, creation of study related documents (protocols, case report forms, Informed consents, Clinical trial agreements, study reports), organizing IRB/EC submissions with follow-through to ensure successful progress
• Accountable for autonomously conducting clinical studies on schedule and within budget while ensuring high quality and compliance
• Perform on-site and remote site qualification visits, site initiation visits, interim monitoring visits and site close out visits
• Conduct clinical study monitoring to ensure regulatory and protocol compliance as well as overall data accuracy in accordance with the study clinical monitoring plan
• Complete source data verification of clinical study data entered in an Electronic Data Capture (EDC) system or on a case report form at sites or in data listings to ensure regulatory and protocol compliance and overall accuracy
• Liaise with sites and help in internal audit/inspection and ensure sponsor audit readiness
• Liaise with external vendors and sites to negotiate contracts and budgets in partnership with the legal team and management
• Track study progress and provide regular status reports
• Work closely with Biostatisticians on data analysis, interpretation and synthesis, in order to…