Cognizant is Hiring: Process Specialist – Clinical Data Management/ Pharmacovigilance

Process Specialist- CDM/PV

Location: MUMBAI / India
Position: Process Specialist – CDM/PV

Employment type: Full-time

Work model: Hybrid

Experience Required: Minimum 3.5 years in Clinical Data Management (CDM)

Job Summary:

Cognizant, a global leader in IT and professional services, is currently hiring experienced Process Specialists in Clinical Data Management (CDM) or Pharmacovigilance (PV). This role is ideal for professionals with a solid foundation in CDM and hands-on exposure to at least two clinical trial phases: Start-up, Conduct, or Close-out.

Key Responsibilities:

• Data Management Execution:

  • Perform data cleaning, execute manual/system checks

  • Manage discrepancies and queries, resolve issues

  • Support database lock activities and maintain relevant trackers

• Process Improvement & Compliance:

  • Participate in innovation and continuous improvement initiatives

  • Ensure all documentation is archived per audit and compliance standards

  • Monitor SLAs and collaborate with team leads to mitigate gaps

• Study Management:

  • Provide support across multiple clinical trials and therapeutic areas

  • Contribute to setup activities like DMP, edit checks, and data transfer specifications

  • Execute User Acceptance Testing (UAT), SAE reconciliation, and archival tasks

• Technical & Client-facing Capabilities:

  • Work with tools like Medidata RAVE, Veeva EDC, and Spotfire

  • Manage third-party data (e.g., Labs, PK, Imaging)

  • Communicate directly with clients and provide mentorship when needed

Required Skills & Experience:

• Minimum 3.5 years of relevant experience in CDM

• Hands-on experience with study setup, conduct, and close-out activities

• Strong exposure to tools such as RAVE, VEEVA, and knowledge of Spotfire

• Experience in:

  • Query handling, Post-production changes

  • SAE, Lab, eCOA/ePRO, PK/PD reconciliation

  • Dataset review, Freezing, and Study lock processes

• Added Advantage:

  • Client-facing experience

  • Mentoring junior team members

  • Experience across diverse therapeutic areas

Why Join Cognizant?

Cognizant offers a collaborative, innovation-driven environment where you can grow your expertise and be part of global healthcare advancements. If you are a detail-oriented professional with a passion for data quality and process excellence, this role is for you.

Apply now and become a part of Cognizant’s world-class Clinical Development team.

APPLY HERE