IQVIA Released Job Openings On 10/03/2022.The Company offers commercial, physical, and biological research and development services, as well as value-based analyses, research studies, clinical management analytics, and health outcome optimization services.Application form link provided at the end of post. Eligibility for the Clinical Data Management as follows.
Vacancy Details:
IQVIA Recruiting B.Pharma/M.pharma/B.sc/M.sc Candidates with 02+ years of Experience for Clinical Data Management Position.Complete Details for the Clinical Data Management as follows.
Important Details :
- Location : Hyderabad/Secunderabad, Chennai, Bangalore/Bengaluru, Delhi / NCR, Mumbai (All Areas)
- No of Vacancies:Not Disclosed by Recruiter
- Details of Salary: Not Disclosed by Recruiter
- Opening date for online Application:10/03/2022
- Mode of application :Online
- How To Apply: Interested please share your updated cv at vaishnavinandkishor.kamble@iqvia.com
Related Job: Wipro Telephonic Interview For Undergraduates & Graduate Freshers & Experienced (Send your CV through WhatsApp)
Job Description/Skills Required
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