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| Job Location | Kolkata |
| Education | Not Mentioned |
| Salary | Not Disclosed |
| Industry | IT - Software |
| Functional Area | General / Other Software |
| EmploymentType | Full-time |
Job Title: Team Leader/ Associate (Full time employment) Skillset: e-TMF/ Document Specialist Line of business: Medical Devices & Pharma Services Work timings: 24/ 7 rotational (night shifts will prevail) Work Location: Kolkata (candidate who is out of transport boundary will have to relocate to Kolkata vicinity as per our transport team guidelines) Department: Wipro DOP Hierarchy in Wipro: Associate (AA) then Team Leader (B1) then Group Leader (B2) then Senior Group Leader (B3) then Manager (C1) then Senior Manager (C2) Responsibilities: Understanding of clinical documents Trial Master File (TMF)- like, Safety, Submission and R&D related documents Ensure the understanding of Clinical Trials in general Ensure the identified properties and features from clinical documents are correct Have understanding of artifacts and attributes associated with documents Conduct Quality Checks involved Working Experience in: Clinical document management system Clinical research monitoring, pharmaceutical, CRO or healthcare industry Knowledge of ICH GCP, 21 CFR part 11 regulations Working knowledge of clinical essential documents, including trial master file and clinical submission documents Basic Minimum Qualification Requirement: Bachelor s/ Master s Degree in Life Sciences, Pharma, Clinical Research and/or a Scientific Degree,
Keyskills :
document management systemcustomer service clinical researchpeople management management systemmanaging processes document manage