Website Katalyst Healthcares & Life Sciences
Katalyst Healthcares & Life Sciences
Company : Katalyst Healthcares & Life Sciences
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:
- Bachelor'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.