Clinical Data Specialist

Project Role : Clinical Data Specialist (UAT)

Work Experience : 2-5 Years.

Work location : Kochi / Kolkata / Bangalore

Work Mode : Hybrid

Must Have Skills : Clinical data management, Start up, UAT Shift Timings : 5 : 00 am -2 : 00 pm / 2 : 00 pm – 11 : 00 pm. The shift assignment is purely based on project requirements and the candidate must be open to working in either of two shifts. FYI : Transportation boundary is 35 KM. no exceptions.

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.

Job Responsibility :

• 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
• Interprets the study protocol. Providing knowledge in validation tasks and performing database validation efforts to ensure delivery of high-quality databases.
• Accountable for overall quality and delivery of the validation effort.
• Develop and test databases and edit specifications.
• Meeting objectives as assigned.
• Develop and test databases and edit specifications, this includes :
• Performs UAT for Edit Checks and Database
• Updates the Edit check status appropriately
• Communicates issues for erroneous Edit Checks to the programmer within the Data Management Plan
• Communicates any documents updates or uncertainties to the Lead Data Manger within the Data.

Technical Skills :

Educational Qualification :