Clinical Data Manager

0 - 4 years

0 Lacs

Posted:19 hours ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a Clinical Data Manager, your role involves developing and implementing data management plans for clinical trials, ensuring data quality and integrity throughout the trial, and collaborating with cross-functional teams to identify project priorities and timelines. You will also be responsible for developing and maintaining study-specific data management documents, managing data quality assurance procedures, and ensuring adherence to regulatory compliance by following relevant guidelines and standard procedures. Key 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 Qualifications Required: - 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 In addition to the responsibilities and qualifications mentioned above, the company offers the following benefits: - Health insurance - Paid sick time - Provident Fund Please note that this is a full-time, permanent position suitable for freshers in clinical data management. The work location is in person.,

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