Senior Manager, Clinical Project

POSITION SUMMARY:

This position will be responsible for managing and meeting the objectives of AtriCure clinical study projects(s). The Senior Clinical Project Manager has a proven competency in clinical research with experience in all aspects of clinical trial execution from start up to data reporting. This position is responsible for leading the execution of AriCure’s clinical study project(s) acting as the primary liaison with clinical study site(s), outsource partners and internally interfacing across all functional disciplines within the company.

ESSENTIAL FUNCTIONS OF THE POSITION:

• Manages all aspects of program activities including budget and project planning.
• Oversee the planning and execution of clinical study(s) to ensure that deliverables are conducted with integrity, completed to achieve scheduled milestones and goals and within budget.
• Coordinates and consults with the cross functional project team, project stakeholders and the clinical study team providing direction to internal and external study team members as required.
• Monitors study progress from internal study team members and outsource partners for accuracy and trending.
• Presents study plans, provides ongoing updates and progress reports to internal and external stakeholders.
• Assists in ensuring trial is “audit ready” at all times
• Evaluates integrity and quality of clinical data in preparation for study summary reports for presentations, publications, and submissions.
• Contributes to the development and implementation of site corrective actions to address any site compliance issues.
• Oversees activities delegated by VP, Clinical Affairs and/or VP, Regulatory Affairs specific to the company’s clinical/regulatory submissions.
• Supports all company initiatives as identified and in support of the quality system and other regulatory requirements.

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

• Advanced written and verbal communication skills.
• Expertise with GCP’s and regulatory compliance guidelines for clinical trials (E.G., applicable ISO Standards, FDA).
• Regular and predictable work performance
• Ability to travel occasionally (no more than 20%)
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as required
• Ability to successfully work with others
• Additional duties as assigned

BASIC QUALIFICATIONS:

• Bachelor’s degree required, in the Sciences preferred, or demonstrated equivalent combination of education, training and experience.
• Minimum 5 years’ project management experience directly supporting medical device clinical research or similar experience in medical/scientific area, plus 1-3 years of experience managing projects and working with clinical professionals within a team, as well as working in a cross-functional product development setting.

OTHER REQUIREMENTS:

• Ability to regularly walk, sit, or stand as needed
• Ability to occasionally bend and push/pull as needed
• Ability to pass pre-employment drug screen and background check