Sr. Manager, Clinical Affairs

Location: Minneapolis, MN
Department: Clinical Affairs
Employment Duration: Full Time Regular
FLSA Status: Exempt
Job Code: 2019-158
Office based or Remote: Office Based

Description

AtriCure, Inc. provides innovative technologies for the treatment of Atrial Fibrillation (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 and only medical device to receive FDA approval for the treatment of long standing persistent Afib. Additionally, our AtriClip Left Atrial Appendage (LAA) Exclusion System products are the most widely used LAA management devices worldwide.  For more information, visit AtriCure.com or follow us on Twitter @AtriCure.

 

POSITION SUMMARY:

The Sr. Manager of Clinical Affairs plays a key leadership role for the Company’s Clinical Affairs including study preparation, execution and reporting of clinical data.  Significant hands-on implementation work is required in this role.

 

The Sr. Manager of Clinical Affairs will have a strong and demonstrated background in creating and executing clinical strategy and influencing internal and external customers within the product development team to drive business results.  This candidate is accountable for clinical trial operations and project management activities, for providing work direction to in-house and field based clinical research staff, and for successful completion of clinical milestones in compliance with applicable regulatory and business standards. The candidate is responsible for coordination with cross-functional counterparts and contract research organizations (CROs) across global studies in conformance with applicable regulatory requirements to meet business objectives.

 

The Sr. Manager of Clinical Affairs will aid in establishing and compliance with standard processes and best practices, in addition to maximizing metrics and reporting on clinical activities. Significant interactions with physician investigators and study staff are required during the clinical investigation to ensure the clinical data reported are complete, accurate and true.

 

This position requires critical thinking skills with respect to program strategy and clinical operations execution to evaluate the safety and effectiveness of new and existing products.  This work is accomplished with minimal oversight, requires frequent contact with internal and external customers, and has significant impact to the business.

 

ESSENTIAL FUNCTIONS OF THE POSITION:

  • Develop and execute clinical strategies.
  • Design and execute global studies for regulatory submissions, reimbursement and product adoption, including clinical study documents (protocol, case report forms, investigator brochures, clinical study reports, etc.), study implementation and data management activities.
  • Foster and maintain strong relationships through direct interactions with medical advisors, clinical leaders and study investigators and their staff.
  • Negotiate contracts with hospitals, consultants, investigators, CROs, database management firms and outside suppliers.
  • Oversee administrative activities associated with the clinical department including procedures, training of key personnel and preparation and maintenance of objectives and budgets.
  • Oversee clinical data analysis and review.
  • Partner with cross-functional team members to meet business objectives.
  • 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. 
  • Implement best practices and standards for trial management in collaboration with other members of the clinical operations team, including establishment of procedures (SOPs or DOPs). 
  • Lead initiatives to build clinical department infrastructure.
  • In collaboration with QA, ensure that clinical trials are conducted in compliance with applicable regulatory requirements and inspection-ready 
  • Other duties as assigned.

 

ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:

  • Regular and predictable worksite attendance
  • 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 or demonstrated equivalent combination of education, training and experience.
  • At least 5 years of clinical operations leadership experience in a medical device (preferred) or pharmaceutical/biotech environment, including global experience.
  • Global clinical trial management experience preferred 
  • Experience managing CROs and vendors throughout entire clinical operations life cycle 
  • Proven success participating in cross-departmental (senior management, regulatory, QA, CMC, program management, finance, business development, pharmacovigilance, medical affairs, clinical development, medical writing) clinical strategy, planning and implementation activities 
  • Proven success in leading and coordinating cross-functional clinical operations teams (e.g., clinical operations, data management, biostats, clinical supply chain) 
  • Direct experience with sponsor, site, and/or vendor preparation for and participation in regulatory inspections, with global experience preferred 
  • Excellent working knowledge of FDA regulations and expectations, Good Clinical Practice, ICH guidelines and clinical operations best practices 
  • Collaborative and team-oriented 
  • Demonstrates strong problem-solving, communication and leadership skills 
  • Demonstrates strong organizational, project management and soft skills
  • Previous experience with AFib and / or Structural Heart interventional device studies, a plus 
  • Ability to travel 25%

 

PREFERRED QUALIFICATIONS:

  • Knowledge of electronic data capture systems and web-based clinical trial management tools
  • In-depth understanding of common cardiovascular device product development processes / requirements
  • Change agent and collaborative team player
  • Strong team leader with execution focus

 

OTHER REQUIREMENTS:

  • Ability to regularly walk, sit, or stand as required
  • Ability to occasionally bend and push/pullAbility to regularly lift up to 10 pounds, occasionally lift up to 20 pounds
  • Ability to pass pre-employment drug screen and background check

 

AtriCure is an Equal Employment Opportunity/Affirmative Action employer. 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).

 

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 has a variety of benefits available for US based employees and their families.  Examples include Medical & Dental beginning day 1 of employment, 401K plus match, 15 days of paid Parental Leave, in addition to maternity leave, for new moms and dads, Volunteer Time off, Pet Insurance, and more.   Corporate-based employees also have full access to our on-site fitness center and cafeteria.  To see a complete list of our benefits, please visit our careers website: https://www.atricure.com/benefits




Agency and Third Party Recruiter Notice:

 

Agencies that submit a resume to AtriCure must have a current Agreement in place, executed by a member of the Human Resource/Recruiting Department. In addition agencies may only submit candidates to positions for which they have been invited to do so by one of our Recruiters or Recruiting Managers. All unsolicited resumes sent to us will be considered property of AtriCure and AtriCure will not be held liable to pay a placement fee.


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