Note: The job is a remote job and is open to candidates in USA. AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. The Senior Manager, Clinical Operations serves as a subject matter expert and advisor to Clinical Operations and Programs on Monitoring/Site Management and Trial Operations related matters, overseeing performance and trends in site lifecycle management and ensuring compliance with applicable regulations.
Responsibilities
- Acts as a Subject Matter Expert to Clinical Programs and Operations team on site Start-Up, Monitoring, and Site Management (including Trial Operations) aspects of clinical research
- Ensures compliance of clinical sites with regulations and internal procedures
- Provides work direction, guidance, mentoring and support to CRAs, and trial support staff on start-up, site management, clinical trial operations and monitoring practices with continuous improvement objectives of efficiency and quality. Includes but not limited to device accountability, processing of trial payments, eTMF management, processing of clinical trial agreements, trial submission preparation to regulatory agencies etc
- Represents Clinical Operations on department initiatives related to development of policies and procedures, implementation of global clinical quality systems (e.g. eTMF) and regulation changes
- Responsible for applicable trial metrics to ensure timelines, quality and compliance are met
- Fosters and maintains strong relationships through direct interactions with medical advisors, clinical leaders and trial investigators and their staff
- Supports negotiation and execution of contracts with hospitals, consultants, investigators, CROs, and other vendors as needed
- Oversees administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets
- In partnership with Clinical Programs, oversees clinical trial enrollment and data compliance strategies
- Partners with cross-functional team members to meet business objectives
- Ensures that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices
- Implements best practices and standards for trial execution in collaboration with other members of the clinical operations and programs team, including establishment of procedures (SOPs or WIs)
- Other duties as assigned
Skills
- Bachelor's degree required
- At least 10 years of global clinical operations leadership experience in a medical device (preferred) or pharmaceutical/biotech environment
- Direct management of monitoring and site management (CRA) personnel (remote and onsite), providing work direction, guidance and mentoring for execution of clinical trials
- Proven experience working with EDC, trial management, reporting and documentation systems
- Experience managing CROs and vendors throughout entire clinical operations life cycle
- Proven success participating in cross-departmental (Senior Management, Regulatory, Quality, Program Management, Finance, Medical Affairs, Clinical Development etc.) clinical strategy, planning and implementation activities
- Excellent working knowledge of FDA regulations and expectations, Good Clinical Practice, ICH guidelines and clinical operations best practices for the conduct of global pre- and post-market clinical trials
- Experience working in a cross-functional team setting in different locations and geographical regions
- Demonstrates strong problem-solving, communication and leadership skills
- Demonstrates strong organizational, project management and soft skills
- Proficient in Microsoft office
- Strong team leader with execution focus
- Ability to work independently and to solve complex problems
- Ability to travel 25%
- In-depth understanding of common cardiovascular device product development processes / requirements
- Change agent and collaborative team player
- Direct experience with sponsor, site, and/or vendor preparation for and participation in regulatory inspections, with global experience
- Proven experience contributing or leading department/organizational initiatives with major impact on process improvement work and/or work efficiencies
- Previous experience with AFib and / or Structural Heart interventional device studies
- Customer focus with ability to develop excellent relationships with internal and external partners
Benefits
- Medical & Dental beginning day 1 of employment
- 401K plus match
- 30 days of paid Parental Leave, in addition to maternity leave, for new moms and dads
- Volunteer Time off
- Pet Insurance
- Corporate-based employees also have full access to our on-site fitness center and cafeteria
Company Overview