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Process Specialist-CDM/PV

JD 7

Job Summary

Data Manager

Should have 3.5+ years of experience in CDM with exposure to any 2 phases from Start up, Conduct, Close out.Exposure to UAT, SAE Reconciliation, Archival and tools like Medi Data and RAVE.

Responsibilities

JD CDM:

1 Execute Data Management Activities I.e., Data Cleaning, Executing Manual and System checks, Update relevant trackers, Discrepancy and query management, Issue resolution, Database lock activities.

2 Participate in innovation and process improvement initiatives.

3 Identify and develop action plan in coordination with the TL for activities not meeting the client SLAs.

4 Archive all necessary information for audit purposes according to quality and security requirements, to ensure reliable and timely retrieval of documentation and information.

5 Support multiple clinical trials, across diverse therapeutic areas, to successful conclusion and provide technical oversight when required.

6 Study Setup hands on experience.

7 Working exposure in RAVE/VEEVA EDC, Knowledge of Spotfire reporting tool ,8 Third party data handling experience (Lab, PK, Image etc), Client facing role (experience in client communication

Setup experience should have knowledge of:

  • DMP (Data Management Plan ) creation, Edit check creation , Data Transfer specification creation, UAT knowledge (not mandatory).

Conduct Experience

  • Data Cleaning experience(Query Handling), Post Production Changes, SAE reconciliation, LAB Reconciliation, ECOA/EPRO Reconciliation, PK/PD Reconciliation, Dataset review etc.

Study Lock

  • Freezing/Locking, Should have good experience of Study lock
  • Client facing role and Mentoring are added advantage.

The Cognizant community:
We are a high caliber team who appreciate and support one another. Our people uphold an energetic, collaborative and inclusive workplace where everyone can thrive.

  • Cognizant is a global community with more than 300,000 associates around the world.
  • We don’t just dream of a better way – we make it happen.
  • We take care of our people, clients, company, communities and climate by doing what’s right.
  • We foster an innovative environment where you can build the career path that’s right for you.

About us:
Cognizant is one of the world's leading professional services companies, transforming clients' business, operating, and technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build, and run more innovative and efficient businesses. Headquartered in the U.S., Cognizant (a member of the NASDAQ-100 and one of Forbes World’s Best Employers 2024) is consistently listed among the most admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com

Cognizant is an equal opportunity employer. Your application and candidacy will not be considered based on race, color, sex, religion, creed, sexual orientation, gender identity, national origin, disability, genetic information, pregnancy, veteran status or any other characteristic protected by federal, state or local laws.

Disclaimer: 
Compensation information is accurate as of the date of this posting. Cognizant reserves the right to modify this information at any time, subject to applicable law.

Applicants may be required to attend interviews in person or by video conference. In addition, candidates may be required to present their current state or government issued ID during each interview.

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