Senior Clinical Study Manager

🔥 32 minutes ago

🇪🇸 Spain – Remote

💵 $137.3k - $242.3k / year

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 0%

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Intuitive

WebsiteLinkedInAll Job Openings

5001 - 10000 employees

Founded 1995

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Intuitive is a company known for its innovative surgical technologies, including the da Vinci Surgical Systems which are used for minimally invasive procedures. With three decades of demonstrated performance, Intuitive focuses on advancing healthcare by providing structured and measurable technology training pathways for surgeons, physicians, and OR care teams. Their vision is to improve patient outcomes through less invasive surgical care. Intuitive also offers a visual media platform for collaboration and learning, known as the Da Vinci Hub, and the Simnow platform for surgical training. The company is involved in ongoing innovation to explore new possibilities in surgical care.

📋 Description

• Lead assigned clinical research activities • Partner with stakeholders, investigators and KOLs to develop study designs, concepts, protocols and study outlines • Plan and execute pre-market and post-market clinical studies • Manage site selection, patient recruitment projections, site start-up, enrollment and follow-up • Prepare protocols, case report forms, informed consents, clinical trial agreements and study reports • Organize IRB/EC submissions and follow through on study progress • Conduct studies on schedule, within budget, with high quality and compliance • Perform site qualification, initiation, interim monitoring and close-out visits, both on-site and remotely • Conduct monitoring for regulatory and protocol compliance and data accuracy • Complete source data verification in EDC systems, case report forms or data listings • Liaise with sites and support internal audits, inspections and sponsor audit readiness • Negotiate vendor and site contracts and budgets with legal and management • Track study progress, provide status reports and manage site payments and financial tracking • Collaborate with biostatisticians on data analysis, interpretation, clinical study reports and scientific publications • Organize study meetings and activities • Mentor junior clinical study managers and guide CRAs and CTAs • Follow corporate SOPs, GCP and US/OUS regulatory guidelines • Conduct literature searches, critically appraise scientific literature and write clinical summaries • Review and revise Clinical Operations SOPs for process improvement • Support post-market research, market-trend analysis and Health Economics and Outcomes Research activities • Work with investigators on manuscripts, abstracts, slide presentations and posters • Support regulatory submissions and approvals for pre-market studies and 510(k)s, including responses to regulatory questions

🎯 Requirements

• Previous experience implementing, helping and managing medical device trials • Significant knowledge of clinical and/or outcomes research study design • Proven experience in protocol and ICF development and writing clinical sections for regulatory submissions • Proven experience conducting literature searches, reviews and appraisal of scientific data • Knowledge of Good Clinical Practice ICH/GCP and other applicable regulations • 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 based on business requirements • Ability to manage multiple projects and priorities • Strong communication, presentation and relational skills with high attention to detail and organization • Ability to learn quickly, adapt to shifting requirements and self-educate on surgical specialties • Ability to drive project teams consisting of CRAs and CTAs • Minimum advanced degree in a scientific/bioengineering field (M.S., Ph.D. or M.D.) with a minimum of 5 years of experience in clinical research, or Bachelor's degree in a scientific/bioengineering field with a minimum of 8 years of experience in clinical research is preferred, or a minimum of 10 years of experience in clinical research with relevant training • Knowledge of statistics, statistical methods and design of experiment highly preferred • Experience working in a hospital environment and with nurses and surgeons preferred • Current proof of vaccination against certain diseases, including COVID-19, may be required • Must comply with applicable export-control requirements where applicable

🏖️ Benefits

• Remote work arrangement; employees come onsite when requested by the leader • Incentives • Benefits • Equity • Reasonable accommodations for qualified individuals with disabilities • Equal employment opportunity and anti-discrimination protections • Potential vaccination coverage requirements depending on role