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2+ years
Preferred by Comapny
10 Nov. 24, 2024
Job Description
Job Type: Full Time Education: M.Pharma Pharmacology/Pharm D Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: Sr/Officer (PK Studies)

Department: Clinical Data Management and Biostatistics & Programming
Location: Ahmedabad, India
Reporting To: Project Head


About Lambda Therapeutic Research Ltd.

Lambda Therapeutic Research Ltd. is a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with operations in Poland, the UK, and the USA. With over 20 years of service and a workforce of 1,500+ employees worldwide, Lambda provides full-spectrum clinical trial solutions to the biopharmaceutical and generic industries.

Lambda's mission is to deliver innovative, high-quality clinical research solutions through expertise, advanced technologies, and a commitment to excellence.


Overall Purpose

The role involves performing pharmacokinetic (PK) analysis for clinical studies, particularly in Bioavailability and Bioequivalence (BABE) studies, ensuring regulatory compliance, and collaborating across teams to ensure quality outcomes.


Key Deliverables

  • Pharmacokinetic Analysis: Perform PK/PD (Pharmacokinetics/Pharmacodynamics) data analysis and statistical evaluations for clinical studies.
  • Study Design and Regulatory Expectations: Ensure clarity on regulatory requirements for bioequivalence study designs and criteria.
  • Collaboration: Coordinate with project teams, QA, and regulatory authorities to maintain compliance with Good Clinical Practices (GCP) and Good Laboratory Practices (GLP).
  • Quality Improvement: Lead initiatives to enhance resource management, training, and quality.

Allied Responsibilities

  • Validate computer systems related to clinical data management.
  • Take on additional responsibilities as assigned by the Head of the Department.

Required Qualifications

  • Educational Background:
    • M.Pharm in Pharmacology or Pharm D.
  • Experience:
    • Minimum 2 years in clinical data statistics with a focus on PK studies.
  • Skills:
    • Knowledge of BABE studies and PK/PD analysis.
    • Proficiency in basic statistical tools and relevant software.
    • Fluency in verbal and written communication (English and Hindi).

Competencies

  • Technical Skills: Strong understanding of pharmacokinetics and clinical study data analysis.
  • Soft Skills: Accountability, teamwork, communication, and leadership abilities.
  • Cultural Fit: Alignment with Lambda’s values of innovation, excellence, and quality.
  • Organizational Skills: Flexibility, planning, and efficient resource management.

What Lambda Offers

Lambda is committed to hiring and nurturing talent that embodies passion and a commitment to excellence. As part of the team, you will contribute to advancing innovative solutions for clinical research, with opportunities to grow within a globally respected organization.