Location: Bangalore
Industry: Pharma / Healthcare / Clinical Research
Application Deadline: 12 October 2024
Job Description
AstraZeneca is seeking a Senior Clinical Data Manager II to coordinate Clinical Data Management (CDM) deliverables for assigned studies. This role is pivotal in ensuring the smooth operation of data management tasks, risk identification, and collaboration with data management vendors.
Key Responsibilities
- Coordinate CDM deliverables on assigned studies and serve as the first line of contact.
- Oversee day-to-day operations of CDM, ensuring compliance with Trial Master File requirements.
- Identify risks and collaborate with DM vendors to mitigate them.
- Contribute to CDM activities related to regulatory inspections/audits.
Candidate Profile
- Education: University or college degree in life sciences, pharmacy, nursing, or a related field.
- Experience:
- Knowledge of Clinical Data Management in the Biotech/Pharma/CRO industry.
- Familiarity with Good Clinical Data Management Practices (GCDMP) and relevant regulations.
- Experience with clinical databases, EDC systems, and query management.
- Proven ability to manage multiple projects and deadlines.
- Skills:
- Excellent written and verbal communication.
- Strong organizational, analytical, and attention to detail.
- Ability to work in a global team and with external partners.
- Knowledge of SQL or SAS software is a plus.
- Understanding of CDISC data standards and practices.
- Experience leading clinical studies as Data Management Lead.
Additional Information
Join AstraZeneca in making a meaningful impact on healthcare while advancing your career in a dynamic environment. We value innovation, collaboration, and a commitment to excellence.