Intern position in Cyber & Digital Trust team at PwC. Join diverse teams to unlock potential and navigate risks for leading organisations.
About the role
- Director overseeing risk management for clinical trials at Johnson & Johnson. Leading a team to ensure quality and compliance in clinical trial programs.
Responsibilities
- 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
Requirements
- 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)
Benefits
- Inclusive work environment
- Professional development opportunities
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Tech skills
Location requirements
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