IQVIA Jobs B.sc/M.sc/B.pharm/M.pharm for Clinical Data Management

Sr. Clinical Data Co-Ordinator SR DOC

• Serve as Data Operations Coordinator (DOC) for one or two complex global studies with fewer than 10 operations staff (excludes DE), or serve in a leadership role to a specific DM Task.
• Manage delivery of projects through full data management study life-cycle.
• Manage project timelines and quality; determine resource needs; identify out-of-scope work.
• Serve as Data Operations Coordinator or Data Team Lead.
• Perform comprehensive data management tasks including data review, writing and resolving data clarifications.
• Perform database designer activities for technologies not requiring extensive programming.
• Perform comprehensive quality control procedures.
• Independently bring project solutions to the CDM team.
• Solve issues through using the global issue escalation/communication plan.
• Consult with Standards Group for process issues; communicate ideas for process improvement.
• Assist in developing and implementing new technology.
• 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.
• Interact with CDM team members to negotiate timelines and responsibilities.
• Has the potential work as DTL/LDM on Global Data Management Project

Lab Normal Reviewer

• Reviews Study Documents such as Protocol, ALS, DARS and Laboratory Reference Range Documents
• Coordinating with the Lead Data Manager for all discrepancies found, identifying errors in programming in the lab set ups and review and suggest changes to eCRF specification guidelines
• Prepares the Lab Test Question for the required analytes
• Creates Lab IDs and enter the ranges and units for each analyte as per the lab test question form for Local Lab.
• Creates TESTLAB in database for UAT and DEV environment for testing purpose
• Approval for new Analytes and units from Amgen as and when required
• Performing QC on LNR entries to assure the 100% quality

Lab Data Reviewer

• Protocol Review for lab requirements
• Review of ALS, DARS, DMP, eCRF Completion Guidelines and coordinates with the Lead Data Manager for

all discrepancies found

• New Lab Parameter/New Unit/Textbook Ranges Approval Process
• Review of source document and preparing the LTQ for LNR entry.
• SAS Checks review
• Review of IPD checklists
• PIG update and upload of SAS listings
• LLR Issue Log/Communication e-Logs (lab forms)
• Lab data review (Lab view via J-review) monthly
• Lab Form query resolution (system to site, system to LDR, LDR to site) on daily basis.
• Resolve and issue queries on the lab data to ensure the lab data is clean.
• Performs Quarterly SAS Check review to ensure the quality
• Performing Quality review for the lab process
• Interaction with other LDRs to verify/clarify information on new data issues.
• Attend weekly team meetings, Doc Meetings and Client meetings as when required.

UAT

• 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

Management Plan

• Understand and comply with core operating procedures and working instructions.
• Develop and maintain good communications and working relationships with CDM team.
• Communicate ideas for process improvement
• If Interested please share your updated cv at vaishnavinandkishor.kamble@iqvia.com

Note :- Please Note this is onsite job for Bangalore/Thane Location