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 therapy-specific knowledge ensures alignment to customer definitions of criticality, and informs review and analysis of study data.
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.
Experience:
3 years in clinical operations or healthcare related field.
Education and work experience in project management, life sciences and/or technical field.
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 at the identification of risks in a process, evaluation of likelihood and impact, and the development of effective mitigation and monitoring strategies that are imperfect yet meet the business need.
Proficient in the translation of clinical trial requirements to the technical specifications required for effective data collection.
Skilled at making inferences and connections based on limited information, clearly describing the knowns, unknowns, and alternative explanations.
Intermediate project management skills; developing a multifaceted plan with complex dependencies and holding peers accountable to adherence to the plan while maintaining positive and collaborative relationships.
Intermediate therapy specific knowledge of anatomy, physiology, pathophysiology, therapy and device.
This position is Non-Exempt. Participates in or leads the review of Clinical Research (CR) documents (e.g., protocols, reports and statistical analysis plans) by interacting with various CR groups including: Project Managers, Clinical Scientists and Statisticians. Leads data management activities by working with Clinical Scientists, Clinical Research Associates, Clinical Safety Monitors, Systems Analysts, QC Analysts & Standards Librarian. May draft Data Management Plans and Data Review Plans as required. Leads the development and defines standard and non-standard edit check specifications by utilizing clinical knowledge to create the parameters surrounding data items. Provides significant input to CRF/eCRF design and address technical issues and edit check programming, as well as contributes to the development of data management reports of clinical data. Leads Clinical Data Management activities by using Clinical knowledge, data listings and manual review of eCRFs to issue queries and clean data as required. Contributes to the monitoring of data quality during study conduct. Provides information on issues along with proposed solutions Ensures data snapshots are ready for analysis by following the guidelines established in the DMP and/or applicable SOPs. Ensures database lock/unlock by following the guidelines established in the DMP and/or applicable SOPs. Ensures archiving of the study databases and related documents by following the guidelines established in the DMP and/or applicable SOPs. Leads the preparation and presentation of data management activities by evaluating and testing new systems and by participating in task force initiatives. Bachelor's degree plus 6+ years of related work experience with a strong understanding of specified functional area, or an equivalent combination of education and work experience. Advanced degree preferred.
Pay ranges between $35-41/hr based on experience
Job Tags
Contract work, Work experience placement,