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Scientist, QPP

Scientist, QPP

CytelNagpur, IN
16 hours ago
Job description

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 :

  • 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

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