Lead clinical data management activities for multiple complex studies from study startup to database lock and final reporting.
Develop and manage data management timelines for multiple projects ensuring all milestones are met according to project plans.
Design build and oversee the implementation and management of clinical trial databases using Electronic Data Capture (EDC) systems (e.g. Medidata Medrio or similar).
Develop and oversee maintenance all data management documentation for all clinical studies.
Ensure clinical data is captured accurately and efficiently incorporating appropriate data validation checks and edit checks.
Oversee data validation processes including data cleaning discrepancy management and query resolution.
Ensure data accuracy completeness and compliance with regulatory requirements (e.g. FDA EMA) and industry standards (CDISC SDTM WHO Drug MedDRA).
Perform data review and provide feedback to study teams to improve data quality and resolve issues early in the trial process.
Ensure clinical data management activities are compliant with regulatory requirements (FDA EMA) ICH GCP guidelines and other relevant regulations.
Prepare and contribute to regulatory submissions including clinical study reports and support data auditing processes.
Collaborate with clinical operations biostatistics statistical programming medical writing scientific and regulatory teams to provide data management expertise in clinical trial planning and execution.
Manage independent vendor and CRO biostatistical services performance and oversee compliance with contracts while ensuring budgetary efficiency
Develop implement and continuously improve clinical data management processes and systems.
Lead initiatives to enhance the efficiency and effectiveness of clinical data management including the evaluation of new tools software and methodologies.
Requirements:
Bachelors or masters degree in life sciences health informatics computer science or related field. Advanced degree preferred.
Strong understanding of data structure and data systems.
Minimum of 5 years of experience in clinical data management.
Proven experience managing data across multiple phases of clinical trials
Proficiency with EDC systems (e.g. Medidata Rave Medio).
Strong understanding of CDISC standards (CDASH SDTM Adam) as well as WHO Drug and MedDRA coding.
Familiarity with data reporting tools is a plus.
Thorough understanding of clinical trial processes regulatory requirements (e.g. FDA EMA) and GCP standards.
Strong leadership and project management skills with the ability to manage multiple priorities in a fast-paced environment.
Excellent communication problem-solving and decision-making skills.
Certified Clinical Data Manager (CCDM) or similar certification is preferred.
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