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Parexel

3 Years

Bangalore (Hybrid)

B.Pharm, M.Pharm, Pharm.D, Msc, BSc, Lifesciences

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Are you passionate about clinical research and data management? Parexel, a leading global clinical research organization, is seeking a Clinical Data Analyst I to join their team in Bengaluru. This is an exciting opportunity to contribute to advancing global health through clinical trials and data-driven solutions. Below, we provide a detailed overview of this role, including company background, responsibilities, qualifications, skills, and application guidelines.

Company Introduction

At Parexel, the mission is to improve the world’s health. As a trusted partner in the biopharmaceutical sector, Parexel provides a wide range of clinical development solutions. From clinical trials to regulatory consulting and market access, their work is driven by a deep conviction to make a difference in patients’ lives. Each employee contributes to the development of therapies that have a lasting impact on health outcomes.

Key Responsibilities

1. Data Validation (Cleaning):

  • Lead or support data cleaning and review activities, including query management and manual/SAS listing reviews.
  • Assist with data processing activities, such as external vendor data reconciliation, from database setup to database lock.

2. Data Management Documents/Plans (Trial Master File):

  • Perform and support the creation of data management documents.
  • Ensure proper documentation in compliance with SOPs and ICH/GCP guidelines.

3. Study Start-Up Activities and User Acceptance Testing (UAT):

  • Lead and perform user acceptance testing for clinical database setups.
  • Review protocols and EDC entry screens as needed.

4. Data Tracking and Entry:

  • Track and review Case Report Forms (CRFs).
  • Support data entry where required.

5. Project Quality Management & Compliance:

  • Ensure adherence to SOPs, ICH/GCP guidelines, and study-specific procedures.
  • Lead functional quality control activities on databases and patient data.

6. Training:

  • Maintain compliance with training requirements and participate in on-the-job training.
  • Address development goals and training needs as identified.

Qualifications

  • Bachelor’s degree in a relevant field or other medical qualifications.
  • Relevant industry experience in clinical research and data management.

Required Skills

  • Technical Aptitude: Proficiency with Microsoft Office products and basic computer skills.
  • Clinical Data Management Knowledge: Understanding of data management processes, data validation, and database setup activities.
  • Communication Skills: Strong oral and written communication abilities in English.
  • Attention to Detail: Analytical and methodical approach to tasks with a commitment to quality.
  • Problem-Solving: Evidence of strong logical reasoning and problem-solving capabilities.
  • Team Collaboration: Ability to work effectively in a team environment.
  • Flexibility: Adaptable to changing technical environments and learning new processes swiftly.
  • Medical Knowledge: Basic understanding of medical terminology, coding dictionaries (e.g., MedDRA, WHODRUG), and clinical study team roles.

Application Link

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