The CDM is responsible for all aspects of clinical data management aspects for the assigned global clinical trials from preparation through archiving.

Study responsibilities include:

• Responsible for directing, leading and overseeing the data management activities of the CRO and responsible for overseeing vendors involved in the assigned clinical trials based on metrics and plan
• Assist in CRO contract negotiations together with the company’s Clinical Study Manager and other stakeholders
• Provide input to and/or development of study related materials such as Clinical Study Protocol, Clinical Monitoring Plans, Data Management Plans, eCRF completion guidelines, External Data Reconciliation Plans, SAS Listing Specifications, Lab Data Transfer Plans, etc.
• Monitor and tracking of patient data entry and query resolution in accordance with agreed timelines
• Ensure clinical trials are conducted in compliance with ICH-GCP and other applicable legislations related to Data Management activities
• Review protocol deviations and related data listings for studies to ensure high quality data is provided and identify and resolve structural issues/concerns
• Conduct QA/QC checks of the data recorded in the clinical database in line with the company’s quality standards
• Ensure timely collection of CRF documentation for periodic review
• Contribute to the development and implementation of the quality system for Data Management to ensure efficient processes and the best quality of service across the Biometrics department
• Proactively identify and resolve issues in the assigned clinical trials and escalate in a timely manner, if needed
• Assist the Clinical Study Manager in the preparation of study timelines and budget and delivering studies within timelines, scope and budget, aligned with the clinical development plan and quality in line with the company’s quality standards
• Attend and contribute to Clinical Study Team meetings from Data Management perspective, for the purpose of planning, set-up, conduct and close-out of Clinical Trials
• Take ownership of quality, timelines and budget aspects related to Data Management for your clinical trials
• Maintain oversight of the planning, preparation, set-up, testing/validation, conduct, documentation and filing of Data Management processes and systems from external service/data providers, and facilitating collaboration and integration of processes and systems of multiple external service/data providers involved in a clinical trial.