Data Manager-Clinical Trials
7 days ago
Role & responsibilities
- Handle Data Management Projects independently as Project Lead and responsible for timely completion of all activities as defined in the Scope of Work.
- Coordination with internal and external teams including Sponsors for various activities of the project.
- Meet customer requirements as per Scope of Work and ensures compliance to protocol, applicable regulatory guidelines and SOPs.
- Preparation and review of various project related data management documents and project reports.
- Provide project related trainings to project team and optimum resource utilization.
- Development and Review of SOPs.
- Tracking the status of all study activities.
- Serving as the primary contact with sponsor / CRO / Lab / Vendor for Data Management Activities.
- Provide required trainings to Data Management Teams
- Any other duties as assigned by superior in department.
Preferred candidate profile
Skills and Qualifications:
Knowledge of:
- MS Office
- Requirements of Good Clinical Practices
- Requirements of Good Documentation Practices
- Requirements of FDA 21 CFR Part 11 for Handling of Electronic Records
- Basic knowledge of clinical research
Ability to:
- Work in a team.
- Managing work within timelines
- Take discission
Experience and Education:
- BDS/BAMS/BHMS/ Bachelors in any discipline
- Masters in any branch of science or pharmaceuticals
- Diploma in Clinical Research
- Minimum 2 Years of Experience in Data Management handling end-to-end projects.
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