Scientist, QPP

Job Description (JD) for Scientist, QPP Role :

Summary of Job Responsibilities :

• Reads and understands the Clinical Study Protocols, Cytel Work Request Documents, and Project Requirements.
• Prepares and reviews Pharmacokinetic Analysis Plan (PKAP) using Clinical Study Protocols and Study Specifications.
• Performs Integral data management, data cleaning process, and integration with Phoenix WinNonlin® software.
• PK / PD analysis using Phoenix WinNonlin® 8.1 or higher software, in accordance with study specifications.
• Plays an active role in planning, execution and delivery of pharmacokinetic assignments ensuring on-time quality deliveries.
• Creates Tables, Listings, and Figures (TLFs), and summary reports for regulatory submission.
• Perform quality control and quality assurance of PK deliverables as per the client assignment specifications.
• Should be proactive to pursue advanced technological aspects and mentor the team members in various technical and strategic aspects to meet the organization objectives.
• Co-ordinates with the Client POCs for clarity of specifications, data issues, reviews, schedules, etc.
• Co-ordinates cross-functional activities involving statisticians, SAS® programmers and medical writers involved in pharmacokinetic projects.
• Reads and thoroughly understands applicable compliance standards such as GCP, 21CFR11, ISO 17799 and client’s SOPs.

Qualifications and Experience :

Minimum Education :

Minimum Work Requirements :

Skills :

Basic Knowledge regarding Clinical Trials Methodologies