Clinical Data Specialist II Position
2 days ago
Overview
Lifelancer is a talent-hiring platform connecting professionals with opportunities in Life Sciences, Pharma, and IT. We're seeking an experienced Clinical Data Specialist II to join our team.
About the Role
- We're looking for a highly skilled individual to contribute to all aspects of global clinical trial activities, ensuring timely delivery within budget, quality, and performance standards.
- This role involves leading specific aspects of global clinical trials, collaborating with cross-functional teams, and driving operational excellence through process improvement and knowledge sharing.
- You'll work closely with the Clinical Trial Team to ensure data integrity, scientific plausibility, and compliance with regulatory requirements.
Main Responsibilities
- Contribute to study start-up activities, including protocol development, CRF creation, and Informed Consent Form development.
- Oversee site close-out, final drug accountability, and audit readiness of Trial Master File documentation.
- Implement and enforce standards (SOPs) and best practices for clinical operations and data review within assigned clinical trials and programs.
- Ensure timely reporting of technical complaints, adverse events, and special case scenarios related to Novartis products.
Key Performance Indicators
- Timely, efficient, and high-quality execution of assigned trials within budget and quality standards.
- Proactive operational planning with effective contingency and risk mitigation plans.
- Adherence to Novartis policy and guidelines, as well as external regulations.
- High-quality contributions to study/program-level documents and submissions.
- Strong leadership skills to support team competency building, local/global initiatives, and best practice sharing.
Requirements
- Financial management experience.
- Collaboration across boundaries.
- Operations management and execution.
- Project management expertise.
Skills
- Budget management.
- Clinical research.
- Clinical trial protocol.
- Clinical trials.
- Coaching.
- Data analysis.
- Data integrity.
- Learning design.
- Lifesciences.
- Risk monitoring.
- Trends analysis.
Estimated Salary: $85,000 - $110,000 per year, depending on location and experience.
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