For one of our clients located in the area of Zaventem, we are recruiting a Clinical Data Manager with prior experience in the industry.
Office-based role (4-5 days/week at the client's location).
Job Description
The Clinical Data Manager is responsible for managing the development, documentation, and execution of risk-based quality management systems, as described in the risk assessment, data management plan, and site and central monitoring plans.
As the customer-face of Data Review and its primary liaison with the therapy group, the Clinical Data Manager's in-depth therapy-specific knowledge ensures alignment to customer definitions of
criticality, and informs review and analysis of study data; within Data Review, the Clinical Data Manager's project management of the RBQM system depends on close partnership and collaboration with the Clinical Data Management Analyst, whose technical expertise in data collection and cleaning
processes are critical to the proactive identification and control of risk, and the maintenance of data quality over the study lifecycle.
Responsibilities
- Identification of study specific risks to study conduct and human subject safety; analysis of risks; development and implementation of mitigation strategies.
- Review of study data to detect anticipated and unanticipated issues related to trial data completeness and quality.
- Facilitate multi-stakeholder discussions to review findings, evaluate impact and develop action plans for correction and continued monitoring.
- Conduct Central Monitoring activities, as described in Central Monitoring Plan.
- Direct all data cleaning activity related to assigned studies.
Profile
- University degree in Life Sciences or equivalent
- Minimum 1-2 year's experience as Clinical Data Manager in the industry.
- Fluent in English
- Knowledge of data collection best practices for clinical trials.
- Knowledge of global clinical operations.
- Experience in consultative role, with Subject Matter Expertise, and effectively influencing a team decision to the desired outcome.
- Proficient in the translation of clinical trial requirements to the technical specifications required for effective data collection.
