Role: Clinical Data specialist
Skill: EDC, Rave
Mode: Hybrid
Experience: 3-5 years in Clinical Data management
Job Location: Kochi/Kolkata/Thane/Bangalore
Educational Qualification: Any life science graduate
Good to have: Clinical study startup, conduct, close out with hands on exp in UAT, Validation Query management , Reconciliation and Database lock
Job Overview:
Provide basic and some comprehensive data management expertise to the Clinical Data Management (CDM) team to provide efficient, quality data management products that meet customer needs. May also undertake team leadership activities under the supervision of the Data Operations Coordinator (DOC), Data Team Lead (DTL), or Functional Manager.
Essential Functions
- Serve as a Data Operations Coordinator (DOC) for one protocol with less then 5 operations staff (excludes DE) or 15+ easy to moderately complex central laboratory studies, or serve in a leadership role in a specific data management task (e.g., coder, tester or database designer for technologies that don't require extensive programming expertise) with guidance.
- May serve in the role of back-up to a DOC or DTL.
- May conduct data review.
- May write and resolve data clarifications.
- May lead database audit team.
- May develop and test databases and edit specifications.
- May perform testing of programming.
- May perform clinical data coding. Understand and comply with core operating procedures and working instructions. Meet objectives as assigned. Develop and maintain good communications and working relationships with CDM team.
Qualifications
- Bachelor's Degree Clinical, biological , or related field Req
- Equivalent combination of education, training and experience in lieu of degree.
