Senior Manager, Clinical Operations to Director, Clinical Operations
Clinical Operations
|
Santa Cruz, CA
Hiring Manager: Head of Clinical Development
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Description
This is a unique opportunity for an experienced Clinical Operations Professional to work on multiple clinical studies in USA, EU and ROW.
Responsibilities
- Contract Research Organization (CRO) oversight and execution of Revolution Medicines clinical studies
- Clinical operations functional activities related to the execution of assigned clinical programs based upon department and corporate goals and objectives
- Contributing to the development, management, and execution of the Clinical Development Plan (CDP) for assigned clinical programs which includes timelines, budget, and resource requirements
- Responsible for successful management and development of Clinical Operations staff (potentially including clinical program managers/CTMs/CTAs) for project and non-project related tasks
- Oversight of global clinical studies providing direction and oversight to Clinical Program Managers, CTMs/CTAs, as applicable, and CRO Study Teams
- Oversight of timelines, budgets, resources, CROs, and key deliverables to ensure studies are completed on time, within budget and in compliance with Standard Operation Procedures (SOPs), FDA regulations, ICH/GCP guidelines
- Reviewing product design and manufacturing changes to assess regulatory impact and completing any associated regulatory activities
Skills
- Ability to identify critical path activities and articulate and mitigate risks to clinical trial conduct
- Strong working knowledge of FDA Regulations, ICH Guidelines and GCPs governing the conduct of clinical trials
- Experience in leading and managing global phase 1-3 clinical trials within designated timelines, resources, and budgets
- Extensive experience in selection of CROs/ vendors and management of external resources
- Strong communication skills, both verbal and writing
- Demonstrated ability to multi-task, prioritize options, anticipate challenges, and execute on goals as a member of an interdisciplinary team is extremely important
- Working knowledge of data management, data review and analysis, and device safety in structural heart
- Highly collaborative and comfortable in a hybrid work environment
Requirements
- BS/MS Degree in a scientific discipline with a minimum of 10 years of clinical operations experience in the medical device industry
- Minimum of 4 years project and line management experience
- Some travel expected
Overview
Capstan Medical: Creating a new standard for minimally invasive structural heart treatment
At Capstan Medical, we’re driven by an unwavering commitment to transforming the treatment of heart valve disease. By merging surgical robotics with catheter-based technology and next generation implants, we’ve pioneered a patient-optimized approach to repair and replace heart valves.
Our innovative technology offers a significantly less invasive alternative to traditional open-heart surgery while ensuring a precise and reliable placement of the heart valve implant. With these advancements, we may be able to provide patients a solution to their heart valve disease while significantly reducing recovery time and minimizing the risk of complications. With a dedicated team of heart valve device experts and robotics engineers, we are fully committed to developing a comprehensive and transformative solution that will positively impact the lives of individuals affected by this condition.
Capstan Medical is uniquely positioned in Santa Cruz, this gives us access to the amazing technical talent of the bay area but in an environment that we feel is conducive to doing our best creative work. Our office is adjacent to large tracts of open space with bicycle trails straight from the office doors offering access to the hills and beaches of Wilder Ranch State Park for road/mountain bicycle riding, hiking, and surfing.
Come join us and become part of a team revolutionizing heart valve treatment.