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 worldβs 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
- Bachelorβs 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.
