As functional lead of Clinical Risk Management, the Clinical Data Risk Analyst is responsible for set-up and implementation of Central Monitoring on a portfolio of clinical studies.
The Role:
- Recognize, exemplify and adhere to Parexel values, which center on Collaboration, Agility, Integrity and Inclusion
- Recognize the importance of and create a culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs
- Creation and ownership of the Central Monitoring Plan
- Provide input to study risk assessment and propose appropriate and tailored risk indicators for central analysis, in line with holistic data monitoring model.
- Support set-up and testing of data analysis platform
- Review clinical study data and make independent decisions to identify potential site performance and site organization issues.
- Manage operational risk log for Clinical Risk Management activities.
- Train and support the project teams about interpretation of Central Monitoring Signals and relevant decision making for study conduct.
- Support preparation, conduct and follow-up of the Quality Risk Review Meetings for effective communication with the cross functional project team to ensure adequate decisions are taken about the study monitoring strategy and effective resolution of site performance issues.
- Oversee Clinical Risk Management project budget, scope of work, forecasting.
- Communicate effectively with the project team: CRAs, Project Managers, Clinical Trial Managers, DM Staff, Medical staff, Scientific Council to ensure adequate decisions are taken about the study monitoring strategy and effective resolution of site performance issue.
- Support cross functional and external Data Analysis Platform users with system use.
- Act as mentor for Central Monitoring team members.
- Travel (approximately 5%) domestic and/or international.
- Other duties as assigned.
To be successful in the role, you will ideally have:
- University/Bachelor's Degree in medicine, science or equivalent degree/experience
- Thorough knowledge of ICH GCP and relevant regulations for the conduct of clinical trials, with specific focus on updates about Risk Based Quality Management and Central Monitoring
- 3-4 years experience in Clinical Research (CRA or DM background), or relevant skillset
- Knowledge of database technologies and processes
- Fluent in written and spoken English.
- Excellent communication and interpersonal skills, attention to detail
- Demonstrate ownership and accountability for achieving results.
- Ability to work within a team environment and manage competing priorities in a changeable environment.
- Proven Functional Lead skills and the ability to work independently and apply critical thinking skills to resolve study related issues.
- Due to the nature of this position, it may be required for the employee to travel. Therefore, dependent on the employee's location, the employee may be required to possess a valid Driver's license and passport.
