Senior Manager, Quality and Compliance

CVS Health•Work At Home-Ohio, OH

7d•$75,400 - $182,549

About The Position

Empowering health care decisions through evidence-based insights. CVS Healthspire™ Life Sciences Solutions is committed to advancing clinical research by translating real-world data into actionable knowledge. The Senior Manger Quality and Compliance will be responsible for leading critical multi-functional team activity to set the strategy and plans for embedding Quality and Compliance across the research units including Real World Evidence (RWE), Safety, Surveillance and Collaboration (SS&C), Recruitment, and others under development. Owns accountability for implementing operational requirements for regulatory compliance, integrating quality measures and leading inspections and audits with Health Authority and Partners including hosting, managing, and responding to audit and inspection findings.

Requirements

6 or more years of Clinical Trial Process and business via Retail Pharmacy / Clinical Background, major Pharma, or Clinical Research Organization
6 or more years of experience with broader healthcare industry landscape and issues among payors, pharmacies, and other care providers and their influence on Clinical Trials

Nice To Haves

Experience working for an IRB
Experience working within a PBM and/or Payer environment.

Responsibilities

Establishes and maintains programs, policies, and procedures, ensuring full compliance to all applicable Regional and Federal regulations, guidance, and laws.
Design, implement and maintain systems and processes to ensure on-going training requirements for scientific and other research staff are met, tracked and available for audit.
Facilitate, track and document Root Cause Analysis, Quality Event and CAPAs with study teams.
Develops actionable insights derived from project management tools, data analysis, and stakeholder feedback to drive improvement.
Applies advanced methods to proactively identify, oversee, design, and implement quality and compliance requirements throughout the life cycle of the study, including post-closure data retention and document management.
Develops methodology for the optimal rollout and measurement of key metrics including processes and work instructions for escalation and internal/external reporting.
Establishes key goals and targets for the team development of critical key indicators to ensure individual and departmental goals and objectives are consistently met.
Owns quality requirements and agreements for ongoing compliance and performance of third-party vendors.
Manage and influence cross-functional partners.