Compliance and Quality Specialist

The Oracle Life Sciences Compliance and Quality team navigates industry and quality standards for market research and real-world evidence studies, and we are passionate about guiding the research consulting teams to understand and apply these standards to successfully fulfill the needs of various stakeholders. We are a dedicated, multi-national team, with an interdependent collaborative culture, leveraging each other's insights and abilities to better support the needs of the research consulting teams and our clients. Join us to grow your expertise in an industry with ever evolving guidelines and standards. What You'll Do:

• Maintain quality standards within Oracle Life Sciences
• Assist in carrying out quality and documentation checks of study folders (e.g. internal audits).
• Review research study materials to ensure compliance with procedures, industry code of conduct (ESOMAR/ EphMRA/BHBIA), data privacy laws (GDPR), and quality standards.
• Interact with global research consulting teams to assess study requirements.
• Assist with administrative tasks
• Create and maintain dashboards to track queries.
• Maintain employee database: update database for leavers/joiners, categorize and file trainings in database.
• Support the Compliance and Quality team to deliver on KPI's as agreed with Senior Management
• Collaborate within the Compliance and Quality team to deliver and track trainings with internal and external stakeholders.
• Contribute as necessary to maintain audit readiness (ISO Certification, Client, Pharmacovigilance, vendor audits)
• Undergraduate degree in administration, clinical / academic / laboratory research, quality, pharmacy or other relevant fields., Performs evaluation of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and suggests recommendations for changes. Conducts and facilitates internal and external audits to identify, evaluate, disclose and appropriately remedy risks and deficiencies with some guidance based on complexity. Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and external audits and inspections. Respond to security and/or compliance related requests and RFPs. Update and maintain internal and externally facing security documentation. Facilitate 3rd party audit activities. Maintain and track required compliance and security training for the GBUS. Maintain and update security and compliance reporting. Facilitate vendor security assessments as needed. Assist in managing security and/or quality, and compliance related projects for the
GBUs.


• Previous experience in market research, healthcare, quality assurance or quality control desirable
• Effective communicator: fluent in English with skillset to assess the target audience to adapt language and vocabulary accordingly
• Organized: diligent with eye for detail and ability to follow procedures
• Dynamic and flexible: capable of multi-tasking to prioritize under challenging deadlines
• Quick learner: attentive listener with capacity to quickly grasp different concepts to put into practice for studies with constantly evolving specifications
• Team player: willingness to collaborate closely within the core team and across multiple teams within the global research consulting organization
• Excellent IT skills (Pack Office)
The ideal candidate: the ideal candidate will be outgoing, approachable, and dynamic, with a keen eye for detail and a great disposition for learning about diverse studies and concepts in a fast-paced environment. The candidate will be naturally curious with an appreciation to share acquired knowledge with the research consulting teams to foster an informative culture.

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