The Clinical Data Analyst III role involves independently performing clinical data validation activities for assigned projects and providing expertise in data management processes. This position requires thorough compliance with corporate quality standards, SOPs, ICH-GCP guidelines, and international regulatory requirements.
Key Responsibilities:
Data Validation (Cleaning)
- Lead and manage data validation activities, including query management, manual/SAS listing reviews, and external data reconciliation.
- Identify and mitigate risks affecting project timelines as part of the Risk Management Plan.
Documentation and Study Management:
- Prepare and manage Data Management (DM) documents according to SOPs and ICH/GCP Guidelines.
- Lead user acceptance testing (UAT) and review protocols/EDC entry screens.
- Provide input on DM timelines and coordinate database setup activities.
Project Quality and Compliance:
- Ensure adherence to SOPs and ICH/GCP Guidelines.
- Lead quality control activities on databases and patient data.
Training and Mentorship:
- Maintain training compliance and conduct on-the-job training for staff and project teams.
- Act as a mentor and Subject Matter Expert on DM processes.
Process Improvement:
- Develop and implement project tools and enhance project efficiencies.
Project Support:
- Analyze project variance and support resource management and project finance inputs.
Required Skills:
- Strong leadership and team collaboration abilities.
- Excellent problem-solving, negotiation, and decision-making skills.
- Attention to detail and commitment to first-time quality.
- Strong communication skills with concise and tailored phrasing.
- Time management, prioritization, and ability to adapt to changing environments.
- Basic presentation skills and a proactive learning approach.
Preferred Experience:
- Experience in the CRO industry is desirable.
Education and Qualification:
- Bachelor’s degree and/or relevant medical qualifications.
- Relevant industry experience is required.
