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Central Data Quality Specialist
2 weeks ago
Job Title: Central Data Quality Specialist
DescriptionThe Central Data Quality Specialist plays a pivotal role in ensuring the accuracy and integrity of clinical trial data through centralized monitoring activities, statistical data review, and proactive risk management. This position involves leading the development of Risk-Based Quality Management (RBQM) plans, conducting study risk assessments, identifying study Key Risk Indicators (KRIs), performing ongoing centralized statistical monitoring, remote centralized data review, and facilitating monthly RBQM meetings.
This specialist works independently and manages report review and issue escalation for more complex studies and/or portfolios of work. Additionally, they may mentor junior colleagues, and support the development of processes, procedures, and other documentation to ensure a high-functioning team.
Key Responsibilities:- Lead Development of RBQM Plan: Collaborate with cross-functional teams to design and implement comprehensive RBQM plans tailored to each study's specific needs.
- Study Risk Assessment: Conduct thorough risk assessments for clinical studies, identifying potential issues and developing mitigation strategies, in consultation with functional team leads and Project Managers.
- Centralized Statistical Monitoring: Perform centralized statistical monitoring & data analysis on study data to detect anomalies, trends, and potential risks, ensuring data accuracy and compliance.
- RBQM Meetings: Facilitate monthly RBQM meetings by reviewing study data, documenting findings, action plans, and coordinating data cleaning activities to support study deliverables.
To be successful as a Central Data Quality Specialist, you will need:
- Bachelor's Degree in a relevant field (life sciences, statistics, data management, clinical operations) or relevant/equivalent combination of education, training, and experience.
- Minimum 5 years' experience in clinical monitoring, clinical trial management, or equivalent.
- Working knowledge of ICH GCP guidelines and the clinical development process.
- Excellent communication skills with the ability to communicate effectively with project team members.
- Strong analytical and problem-solving skills.
- Demonstrated experience with integrated risk planning & management.
- Ability to mentor junior team members.
We offer a dynamic work environment that encourages professional growth and development. As a Central Data Quality Specialist, you will have the opportunity to work on challenging projects, collaborate with experienced professionals, and develop your expertise in data quality management.
If you are a motivated individual with a passion for data quality and a desire to make a meaningful contribution to the success of our organization, we encourage you to apply for this exciting opportunity.
