Data Analyst Level 1
Certara
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Job Description
Job Title: PK Study Support Associate
Job ID: REQ-10063596
Posting Date: October 6, 2025
Location: Hyderabad, India
Job Type: Full-time | On-site | Regular
Division: Biomedical Research
Business Unit: Universal Hierarchy Node
Company: Novartis Healthcare Private Limited
Shift Work: No
Introduction
The Pharmacokinetic Sciences (PKS) technical study support team is responsible for efficient tactical and operational management of clinical studies across global projects. This role enables regulatory compliance, supports data integrity, and ensures timely study completion through collaboration with cross-functional partners worldwide.
The PK Study Support Associate will contribute to building a global center of excellence, supporting PKS Project Team Members (PTMs) by managing and coordinating clinical studies and ensuring smooth execution of pharmacokinetic analyses.
Role & Responsibilities
- Serve as the single point of contact for global PKS clinical project team members (PTMs) for execution or oversight of clinical study support, quality checks (QC), and/or non-compartmental analysis (NCA) of pharmacokinetic data.
- Collaborate closely with global colleagues to maintain and manage an active list of legacy studies handled by the PKS technical study support team.
- Lead and guide the team in executing technical and process requirements to ensure regulatory compliance and timely study delivery.
- Manage and support clinical project execution, working with global PTMs and the Clinical Study Team (CTT) toward study completion and final Clinical Study Report (CSR).
- Evaluate team performance regularly, fostering a high-performing and collaborative team culture.
- Efficiently balance responsibilities as both a team leader and individual contributor within ongoing projects.
Educational Qualification
- Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Biotechnology, or related field.
Experience:
- Proven experience in clinical study management, pharmacokinetics, or related operational roles.
- Demonstrated ability to work across global, cross-functional teams.
Location
Hyderabad, India
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