Data Manager-Clinical Trials

JSS Medical Research

7 - 12 years

10 - 15 Lacs

faridabad

Posted:5 hours ago| Platform:

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Skills Required

data management clinical trial phase

Work Mode

Hybrid

Job Type

Full Time

Job Description

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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