Oversee the execution of data-driven, risk-based trial and program oversight activities
Manage a team of CRM representatives that will provide consistent quality oversight
Provide and lead strategic guidance to CRM representatives on quality risk assessments, risk entries, and mitigation strategies
Approve CQP (Clinical Quality Plans) risk monitoring information
Independently drive quality risk monitoring reviews and coach others
Ensure a strategic communication framework with business partners and quality management governance
Communicate and facilitate risk updates to R&D Business Partners
Develop and ensure a consistent interpretation of issues that require quality investigations
Provide guidance for significant quality issues (SQI)
Provide advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans
Independently lead key inspection processes and inspection tools
Provide remote support for investigational site inspections
Provide independent advice on questions related to research quality and compliance
Participate in CRM, cross-RDQ JJIM, cross-functional, or cross-sector working groups
Work with limited supervision, independently making quality decisions

A minimum of a Bachelor’s degree (scientific, medical, or related discipline)
A minimum of 10 years working in the healthcare industry (pharmaceutical industry, contract research organization and/or healthcare/hospital system)
Demonstrates experience or recognizes potential for people leadership in formal or informal setting
Proven strong GCP Quality and/or clinical trials experience
Excellent interpersonal, oral, and written communication skills
Flexibility to respond to changing business needs
Demonstrated ability to operate in an environment of culturally diverse styles and business approaches
Proficiency in Microsoft Office Applications
Experience with fundamentals of clinical trial risk management (preferred)
Health Authority Inspection experience (FDA, EMA, and other inspectorates) (preferred)

Director, Cross TA Clinical Risk Management

Key skills