Data Manager-Clinical Trials

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.