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Job Title : Data Analyst

Job Number : 00022357062

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I. Position Summary

• Individuals in this role perform data management functions assigned while assisting/supporting the senior clinical data manager in study set up, conduct activities, viz. Discrepancy management, Query management, Issue resolution, Database lock activities, etc. They also help mentor trainees and new joiners in the team.

II. Key Result Areas

  • Review and provide input to Project Data Management Plan
  • Develop study start up deliverables (p/eCRF, DMP, DVS, p/eCRF Instructions) as per the agreed timelines
  • Perform UAT of all applicable Data Management systems.
  • Perform DB (database) lock within timelines
  • Performs tracking of data management activities using study reports/metrics
  • Ensure adherence to Cognizant and Client SOPs(Standard Operating Procedure)
  • Complete all mandatory training courses certifications as applicable to the supported business
  • Effective risk management and issue handling by conducting daily huddle and escalating them on time to DMTL
  • Increase productivity score – to show overall 10% increase in individual score
  • Optimizing 80% utilization, and effective leave planning
  • Zero client escalations
  • Good Client feedback, Client appreciation mails
  • Assist in the development of, testing and rolling out of new tools
  • Document & review all process changes to improve process quality of the team
  • Ensure Individual Productivity levels are achieved as per targets set year on year
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III. Typical Responsibilities

Business / Customer

  • Interact with client by attending client calls/meetings
  • Maintain a culture of high customer service
  • Ensure adherence to quality norms and processes and to Cognizant/ Client SOPs

Project/Process

• Database Set Up

  1. Implement and promote the use of consistent, efficient and high quality processes to meet timelines and deliverables for the site based project teams.
  2. Perform regimen setup and any other randomization-related activities, CRF design and database design activities. E.g. Preparation of data validation specifications (DVS), Data transfer specifications (DTS) etc. and develop edit check and data derivation procedures to support implementation of new clinical trials
  3. Perform database testing
  4. Provide technical expertise in the production and delivery of the study implementation services
  5. Ensure all study start up activities are conducted in compliance with relevant regulatory requirements using agreed standards
  6. Follow-up and get resolutions for issues
  7. Responsible for overall quality and timely completion of post-production/data migrations
  8. Be accountable for quality and timeliness of own deliverables

• Data Administration

  1. Load lab data into databases, perform QC of lab slips and revert back with findings of data administration errors if any to the client
  2. Provide personal metrics to the team lead for team metrics collation
  3. Provide technical expertise in the production and delivery of the study implementation services
  4. Assist in maintaining work instructions for Data Administration activities
  5. Keep abreast of function related issues / activities for effective operation
  6. Maintain study documentation and meet configuration management requirements
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• Data Discrepancy Management

  1. Prepare study documentation like validation procedure specifications, Level-1 corrections documents, CRF filling guidelines etc. for the assigned study
  2. Perform data management activities on the assigned project in a timely and efficient manner including third party data reconciliation.
  3. Update database with query resolutions
  4. Identify and escalate critical issues proactively and also act on issue resolution
  5. Assist in maintaining protocol level documentation of data management activities
  6. Track metrics specified in the data management plan (DMP) or equivalent document for work done in coordiantion with the client.
  7. Provide feedback to the clinical team on protocol and CRF
  8. Assist Biometrician in the process of break blind
  9. Provide ad-hoc data listings as and when needed
  10. Be accountable for quality and timeliness of the deliverables of Safety Data Management
  11. Analyze data from the Safety database and Project database
  12. Determine whether inconsistent data points exhibit acceptable or unacceptable discrepancies
  13. Issue queries for data points that exhibit unacceptable discrepancies, document the status of events in a reconciliation spreadsheet, update the safety and Update Project database with query resolutions, closing out queries
  14. Ensure that all Safety Data Management activities are conducted in compliance with relevant regulatory requirements

People / Team

  • Assist team leads and manage team activities
  • Expected to support/mentor new joinees, interns.
  • Interact effectively with other team members to promote resource sharing and sharing of best practices
  • Complete mandatory training for self as identified in the training plan
  • Participate in knowledge sharing sessions as an when applicable
  • Support process improvements and trainings when applicable
  • Exhibit willingness to perform additional tasks and proactively participate in study calls during a crisis
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IV. Degree of Independence/Supervision required

• Performs complex duties independently according to established guidelines. Refers to supervisor typically for specific interventions / exceptions. Task is reviewed closely on completion.

V. Team Management Responsibilities (wherever applicable)-NA

VI. Qualification:

  • Education: Graduate/Post Graduate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees, preferably with a PG Diploma in Clinical Research
  • Minimum Work Experience Required: 3 years

VII. Additional Info:

  • While performing the essential functions of this job, the associate is required to remain in a stationary position (standing or seated), use a computer keyboard and other office equipment (i.e. printer, copy and fax machines), and view data on a computer screen for up to 95% of their work hours or shift.
  • FLSA Status: Non-exempt

Work Time: 7am to 4pm and also in 4pm to 1am (rotational)

Experience: 25 to 48 months

Compensation: To be discussed

Education: Only B PHARM, M PHARM, Life Science UG and PG, BAMS, BUMS, BDS

This is Subject Matter Expert level role.

Track: LS-Clinical Data Management Role Title: Senior Process Executive (JUNIOR DATA ANALSYT)

Typical Grade: SME (DA)

Location: KOLKATA

Reporting to: TL/TM

Apply Online Here

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