Job Description

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 Minimum Education:

• Master of Pharmacy (M. Pharmacy) / in Pharmacology/Pharmaceutics/Pharmaceutical technology

Minimum Work Requirements

• 4-6 years of hands-on experience in PK/PD analysis, interpretation and reporting of clinical trials data using Phoenix WinNonlin® software.
• Should have profound knowledge in biopharmaceutics, pharmacology, clinical research, pharmacokinetics and pharmacodynamic (PK/PD) concepts.
• Should be proficient in the concepts of Clinical Trials, Good Clinical Practices (GCP), SOPs and regulatory specifications.
• Should have good academic credits and excellent communication skills (oral and written).

Skills

• Expertise in Phoenix WinNonlin® software in creating workflows independently.
• Demonstrated strong understanding of Drug Discovery and Development, PK/PD principles, physiology/pharmacology and biopharmaceutics through scientific presentations, posters, and publications.
• Proficiency in Medical and Scientific writing.
• Proficient in using GraphPad Prism, R Programming and SAS® software.
• Thorough knowledge regarding International Conference on Harmonisation-Good Clinical Practice.

Basic Knowledge regarding Clinical Trials Methodologies