Clinical Data Manager
Katalyst HealthCares & Life SciencesWorcester, MAjob_description.job_card.30_days_ago
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job_description.job_card.job_descriptionBachelor's degree in a relevant field such as life sciences or a related discipline. Freshers in clinical data management of drug development programs. Familiarity with regulatory guidelines such as ICH / GCP and FDA regulations. Strong analytical and problem-solving skills. Excellent attention to detail and organization skills. Good interpersonal and communication skills to work effectively in a team environment.
Responsibilities :
- Develop and implement data management plans for clinical trials.
- Ensure data quality and integrity throughout the trial.
- Develop and maintain study-specific data management documents such as data management plans, annotated CRFs, and database specifications.
- Collaborate with cross-functional teams to identify project priorities and timelines.
- Manage data quality assurance procedures and perform quality control checks.
- Ensure adherence to regulatory compliance by following relevant guidelines and standard procedures.
- Contribute to the development of standard operating procedures (SOPs) and work instructions.
- Prepare and review database validation and user acceptance testing.
- Perform database lock activities, including data reconciliation and database closure.
Requirements :
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Clinical Data Manager • Worcester, MA