Compliance Operations Manager, Clinical Guidelines

Overview

As we celebrate our Centennial year, we invite you to join us in shaping the next century of impact. Be a relentless force for a world of longer, healthier lives as we remain devoted to a future of health and hope for everyone, everywhere. At the American Heart Association, your contribution matters, and so does your career.

 

The American Heart Association has an excellent opportunity for a Compliance Operations Manager, Clinical Guidelines in our National Center office located in Dallas, Texas!

 

This position can be home-based.

 

The Association offers many resources to help you maintain work-life harmonization through your changing needs and life situations. To help you be successful, you will have access to Heart U, our award-winning corporate university, as well as additional training and support, locally.

 

#TheAHALife is our company culture, our way of life, reflecting our diversity, equity & inclusion, our focus on work-life harmonization and our Guiding Values. Discover why you will Be Seen. Be Heard. Be Valued™ at the American Heart Association by following us on LinkedIn, Instagram, Facebook, X (formerly Twitter), and at heart.jobs.

Responsibilities

In this role, you will be responsible for collecting, researching, and reporting on relevant and comprehensive relationships with industry (RWI) and/or Conflicts of Interest (COI) for new or existing volunteers participating in the writing or review of clinical practice guidelines, performance measures, and other clinical documents (joint documents). Additional responsibilities include aligning policies and procedures with the American Heart Association (Association) and American College of Cardiology (ACC) Science Leadership, and to lead our copyright permissions process for inclusion of tables, figures, and algorithms in our clinical guidelines, performance measures, and methodology publications.

• Reviews all relationship disclosures for projects in process from new or existing volunteers. Reviews all reported relationships against the Association/ACC RWI/COI policy.
• Prepares and delivers communications for volunteers, including, but not limited to, 1) slide sets and materials to communicate the policy, 2) presentations on the policy for webinars and meetings, and 3) responses to queries from volunteers regarding specific questions and relationships in which they are, or may be, engaged.
• Work closely with clinical guidelines, performance measures, and joint staff to maintain relationships with all documents in process.
• Analyzes COI/RWI documentation, provides recommendations, and prepares correspondence for ACC and the Association Science Leadership with rationale for participant determinations.
• Researches and compiles information from all companies where relationships are reported by new or existing members of volunteer writing or review committees. Ensures changes are recorded timely and accurately.
• Maintains the Joint Guideline SharePoint Industry database with information from all researched companies. Keeps the database of companies and information regarding previous decisions current.
• Leads the copyright permissions process for guidelines, performance measures, and methodology publications published in the Association and ACC journals. Engages with scientific publications and copyright permissions departments to secure the appropriate permissions for tables and figures that will be published in the clinical guidelines, performance measures, and other methodology documents.

 

Qualifications

• Bachelor's Degree in a related field or equivalent work experience.
• Minimum of four (4) years of experience:
• Soliciting conflicts of interest (COI) / relationships with industry (RWI) from authors on medical journal papers, clinical guidelines, and performance measures.
• Working with volunteer disclosures and reporting.
• Collaborating with and handling volunteer relationships.
• Writing and presentation skills.
• Proficient experience with MS Office Suite (Word, Excel, PPT.).
• May travel approx. 2-3 times per year.

 

Here are some of the preferred skills we are looking for: 

 

• Experience negotiating contracts.
• Familiarity with medical terms, pharmaceutical products and pharma company names.
• Familiarity with clinical research trial terms and process.
• Familiarity with the Institute of Medicine standards for detailed review and guideline development.
• Familiarity with the Sunshine Act and the Center for Medicare and Medicaid Open Payments.
• Knowledge of the Guidelines International Network Conflicts of Interest paper.
• Knowledge of the International Committee of Medica