Are you a skilled Clinical Data Analyst looking to advance your career in the clinical research industry? Parexel, a leading global biopharmaceutical services organization, is hiring for the role of Clinical Data Analyst II in Hyderabad, Bengaluru, and Mumbai. This is a full-time, office-based opportunity to work with a company dedicated to improving global health through innovative clinical development solutions.
Read on to learn more about the job description, required skills, and how to apply.
About Parexel
Parexel is a trusted partner in the clinical research industry, offering a wide range of services, including clinical trials, regulatory consulting, and market access. With a deep commitment to improving patient outcomes, Parexel empowers its employees to make a meaningful impact on global health.
At Parexel, every team member plays a vital role in the development of therapies that benefit patients worldwide. The company fosters a culture of empathy, collaboration, and innovation, ensuring that its values align with those of its employees.
Job Description: Clinical Data Analyst II
As a Clinical Data Analyst II (CDA II) at Parexel, you will be responsible for performing clinical data validation activities on assigned projects. You will work with minimal supervision, ensuring that all tasks are completed in compliance with corporate quality standards, SOPs, ICH-GCP guidelines, and other regulatory requirements.
Key Responsibilities:
- Data Validation (Cleaning):
- Lead data validation activities, including query management, manual/SAS listing reviews, and external vendor data reconciliation.
- Ensure data integrity and accuracy during study conduct and database lock.
- Data Management Documents/Plans:
- Support the setup of Data Management documents, such as Data Validation Specifications, CRF Completion Guidelines, and Protocol Deviation Specifications.
- Ensure proper documentation in accordance with SOPs and regulatory guidelines.
- Study Start-Up Activities and User Acceptance Testing (UAT):
- Review protocols and EDC entry screens.
- Provide input on data management timelines and coordinate operational activities during database setup.
- Data Tracking and Entry:
- Track and review CRFs (Case Report Forms).
- Support data entry as required.
- Project Quality Management & Compliance:
- Perform functional QC activities on databases and patient data.
- Ensure compliance with quality standards and regulatory requirements.
- Training and Mentorship:
- Maintain training compliance and provide on-the-job training to team members.
- Act as a mentor for junior clinical data analysts.
Skills and Qualifications
To succeed in this role, you will need:
Essential Skills:
- Strong problem-solving and logical reasoning abilities.
- Attention to detail and commitment to first-time quality.
- Excellent time management and prioritization skills.
- Ability to work collaboratively in a team environment.
- Strong interpersonal, oral, and written communication skills.
- Flexibility and adaptability to new technologies and processes.
- Fluency in English (written and oral).
Knowledge and Experience:
- Strong technical aptitude with proficiency in Microsoft Office.
- Understanding of data management processes, including data cleaning and database lock.
- Knowledge of ICH-GCP guidelines, regulatory requirements, and Parexel SOPs.
- Experience with Clinical Data Management Systems (e.g., InForm, Rave, Veeva).
- Familiarity with medical terminology and coding dictionaries (e.g., MedDRA, WHODRUG).
- Basic knowledge of SAS programming and CDISC data standards.
Education:
- Bachelor’s degree or equivalent medical qualifications.
- Relevant industry experience in clinical research.
