Senior (5+ years of experience)
Summary of the Role
A Senior Clinical Data Manager will oversee the entire clinical data management process for clinical trials. They ensure the accuracy, consistency, and integrity of data collected during clinical research. With extensive experience in clinical data systems and protocols, they lead data management teams, develop data management plans, and ensure compliance with industry standards and regulatory requirements.
Required Skills
Strong leadership and project management skills.
Excellent communication and interpersonal skills.
Proficient with EDC systems, database management software, and MS Office applications.
Detail-oriented with a strong focus on data quality and accuracy.
Ability to work independently and manage multiple projects simultaneously.
Qualifications
Bachelor's degree or higher in biostatistics, epidemiology, data science, or related field.
Minimum of 5 years of experience in clinical data management within the pharmaceutical or biotechnology industry.
Proven experience in managing EDC systems and clinical databases.
Demonstrated knowledge of regulatory requirements (FDA, EMA, ICH-GCP) and industry standards for clinical data management.
Certification in Clinical Data Management (CCDM) is preferred.
Responsibilities
Lead the development and implementation of data management plans that comply with company standards and regulatory guidelines.
Supervise a team of data managers and ensure that data management tasks are completed accurately and on time.
Coordinate with cross-functional teams to ensure quality control and validation of clinical trial data.
Oversee the setup and maintenance of electronic data capture (EDC) systems and databases.
Monitor data quality metrics and perform regular audits to ensure accuracy and completeness of data.
Develop and implement strategies for data collection, processing, and review to streamline data management procedures.
Liaise with clinical research organizations (CROs) and other external partners to manage data-related activities.
Contribute to the preparation of clinical study reports and documentation for regulatory submissions.