临床数据管理DM

Major Responsibilities
1.Participate in the review of Clinical research documents (eg. Protocols, Case Report Forms, Reports and Statistical analysis).
2.Develop and implement data management plans for clinical trials
3.Create and maintain study-specific databases and perform data quality checks
4.Design and validate case report forms (CRFs)
5.Ensure timely and accurate data entry from multiple sources
6.Collaborate with cross-functional teams in data review and query resolution
7.Manage data transfers and ensure compliance with regulatory requirements
8.Contribute to SOPs, work instructions, and training materials
9.Ensure adherence to timelines, budgets, and quality standards
10.Perform other activities as required.
Qualifications
1.Bachelor’s degree in a science related field.
2.5 years of experience in clinical data management in the pharmaceutical or biotech industry.
3.Working knowledge of Good Clinical Practices, Good Manufacturing Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
4.Knowledge of CDISC standards and regulatory requirements for clinical trials.
5.Working knowledge of Clinical database applications such as EDC.
6.Excellent communication and problem-solving skills.