Senior Clinical Data Analyst Job in Bengaluru, Karnataka at Parexel
Parexel is seeking a dedicated and experienced Senior Clinical Data Analyst (SCDA) to join our team in Bengaluru, Karnataka. This role involves leading and coordinating all clinical data validation activities on assigned projects with a high degree of proficiency and autonomy. Ideal candidates should possess a Bachelor’s degree and relevant industry experience, particularly in clinical research.
About Parexel
At Parexel, we strive to deliver quality and excellence in the field of clinical research. Our mission is to improve patient lives through innovative science and advanced clinical data management practices. We are committed to building an inclusive work environment and fostering a culture of collaboration and continuous improvement.
Job Purpose
As a Senior Clinical Data Analyst, you will independently perform and lead clinical data validation activities. You will provide technical expertise and operational leadership in data management processes, ensuring all tasks are performed in accordance with corporate quality standards, SOPs, ICH-GCP, and other international regulatory requirements. You will act as a subject matter expert on Data Management Systems and processes, providing technical support and expert advice to internal and external stakeholders.
Key Responsibilities
Data Validation and Cleaning
- Lead data validation activities, including query management, manual/SAS listing reviews, and external vendor data reconciliation.
- Highlight issues and risks to delivery, supporting mitigations as part of the Risk Management Plan.
Data Management Documents and Plans
- Perform and support the setup of DM documents, ensuring proper documentation as per SOPs and ICH/GCP Guidelines.
Study Start-Up Activities and UAT
- Lead and perform user acceptance testing on clinical database setups.
- Review protocols and EDC Entry Screens as required.
- Coordinate DM operational activities during database setup and project closeout.
Data Tracking and Entry
- Track and review CRFs and support data entry as needed.
Project Quality Management and Compliance
- Ensure compliance with SOPs, ICH/GCP Guidelines.
- Perform and lead functional QC activities on databases and patient data.
Training and Mentorship
- Maintain training compliance and address training needs.
- Provide on-the-job training and act as a mentor for other clinical data analysts.
- Serve as a Subject Matter Expert on DM operational tasks, tools, processes, and systems.
Process and Project Improvement
- Develop and implement project-specific tools to improve efficiencies.
Project Finance and Resource Support
- Analyze project variance and provide input on scope changes.
Required Skills
- Proven ability to lead and collaborate with global and cross-functional teams.
- Strong problem-solving skills and logical reasoning.
- Advanced interpersonal, oral, and written communication skills.
- Proven time management and prioritization skills with a sense of urgency.
- Advanced technical aptitude, particularly in data management systems and processes.
- Proficiency in Clinical Data Management Systems (e.g., InForm, Rave, Veeva).
- Basic knowledge of SAS and data standards (CDISC).
Knowledge and Experience
- Advanced understanding of data management processes and data validation flow.
- Good understanding of ICH-GCP Guidelines and local regulatory requirements.
- Experience in clinical research and familiarity with medical terminology and coding dictionaries (e.g., MedDRA, WHODRUG).
- Experience from the CRO industry is desirable.
Education and Certification
- Bachelor’s degree and/or other medical qualifications with relevant industry experience.
- Certification or involvement in a professional society or organization is recommended.
Location
This role is office-based only, located in Bengaluru, Karnataka, India. Additional locations include Hyderabad, Chandigarh, and Mohali.
How to Apply
Interested candidates are encouraged to apply online through
Parexel’s career portal.
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Senior Clinical Data Analyst Job in Bengaluru, Karnataka at Parexel[/caption]
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