Senior Clinical Project Manager

AtriCure, Inc.; Mason (OH); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Medical & Dental beginning day 1 of em

401K plus match

Parental Leave

Volunteer Time off

Pet Insurance

On-site fitness center and cafeteria

Job summary

AtriCure, Inc. is seeking a Senior Clinical Project Manager to drive global clinical study execution from start-up through data reporting. You will partner with sites, CROs and internal teams to ensure milestones are met within budget and regulatory expectations.

The role requires leadership of cross-functional teams, strong knowledge of GCP/ISO standards, and the ability to adapt in a fast-paced medical device environment.

Qualifications

• Bachelor's degree in the sciences or equivalent experience.
• Minimum 5 years in project management supporting medical device clinical research.
• Experience coordinating cross-functional teams and CROs.
• Solid understanding of GCP, ISO, ICH, and FDA requirements.

Responsibilities

• Manage day-to-day execution of global clinical studies and programs per plan and budget.
• Oversee program activities including budget and project planning.
• Coordinate cross-functional teams and CROs, guiding internal study teams.
• Monitor study progress, provide updates to internal and external stakeholders.
• Ensure data integrity, audit readiness, and preparation for publications/submissions.
• Lead site corrective actions and align activities with regulatory expectations.

Skills

Project management

Budget management

Regulatory compliance

Cross-functional leadership

GCP/ISO knowledge

Education

Bachelor's degree in Science

Job description

AtriCure, Inc. provides innovative technologies for the treatment of Afib and related conditions. Afib affects more than 33 million people worldwide. Electrophysiologists and cardiothoracic surgeons around the globe use AtriCure technologies for the treatment of Afib and reduction of Afib related complications. AtriCure's Isolator Synergy Ablation System is the first medical device to receive FDA approval for the treatment of persistent Afib. AtriCure's AtriClip Left Atrial Appendage Exclusion System products are the most widely sold LAA management devices worldwide. AtriCure's Hybrid AF Therapy is a minimally invasive procedure that provides a lasting solution for long-standing persistent Afib patients. AtriCure's cryoICE cryoSPHERE probe is cleared for temporary ablation of peripheral nerves to block pain, providing pain relief in cardiac and thoracic procedures. For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

We foster a culture of inclusion by embracing diverse experiences and individuals where everyone's authentic self is welcome. We offer supporting programs and resources that provide enriching and equitable opportunities for each person to contribute professionally and personally.

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 / analysis. 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

• Accountable for day-to-day management and execution all phases of the assigned clinical studies and programs globally, in accordance with strategy, project plans, and budget following applicable regulatory and standard operating procedures.
• 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, clinical operations, 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.
• Ensures adequate clinical data collection, follow-up compliance, and works with other functional stakeholders to address identified issues.
• 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.
• Leadership of internal clinical research teams and CROs to deliver on business objectives. Ensure that clinical trials are properly resourced, managed and executed in accordance with timelines and good quality practices.
• Thorough understanding of project management tools/techniques in order to manage project timelines, milestones, deliverables, dependencies, risks, issues, budgets, actions, decisions, and communications.
• 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.
• Ability to gather information from multiple sources, analyze, integrate, and resolve any conflicting requirements, and drive the clinical affairs organization through any challenges to result in a successful clinical study.
• Comprehensive knowledge of ISO (International Organization for Standardization), GCP (Good Clinical Practice), ICH (International Council for Harmonization), FDA (Food & Drug Administration) & other applicable regulations governing the conduct of clinical trials
• Regular and predictable work performance
• Ability to travel up to 30% depending on the phase of study execution.
• Ability to work under fast-paced conditions
• Ability to make decisions and use good judgment
• Ability to prioritize various duties and multitask as requiredAbility to successfully work with others
• Ability to manage clinical affairs cross-functional team without direct influence and work in a matrixed environment without direct reporting authority.
• 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.

PREFERRED QUALIFICATIONS

• Project management experience with medical device clinical trials.
• Clinical budget management experience/financial acumen.
• Auditing experience.
• Regulatory experience.Ability to maintain a strategic perspective and align activities with business vision and purpose.
• Ability to respond flexibly and positively under conditions of uncertainty or change.
• ACRP or equivalent license/certification.
• PMP or equivalent license/certification.

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

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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
• and more
• Full access to our on-site fitness center and cafeteria

E-VERIFY & EEO POLICY

AtriCure participates in the federal E-Verify program to confirm the identity of and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here https://www.e-verify.gov

AtriCure is an Equal Employment Opportunity/Affirmative Action employer and provides Drug Free Workplaces. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national or ethnic origin, age, protected veteran status, status as an individual with disability, sexual orientation, gender identity or any other characteristic protected by federal, state, or local law(s).

You may access our global privacy policy here: https://www.atricure.com/privacy