Specialist, Clinical Data Management – Hybrid
About The Position
This role is responsible for all clinical programming (including reporting and analytics) deliverables using platforms like Oracle and Veeva, as well as external data captured to support clinical studies. The Specialist will coordinate and participate in the design, build, maintenance, testing, and documentation of data review based on specifications from Global Clinical Data Management, Clinical Research, and Global Safety. They will review the technical feasibility of study team proposed programming/reporting and implement them technically. The role requires effective teamwork to communicate issues and ideas for business improvement, along with an understanding of the Protocol. Support will be provided for the development and reporting of data cleaning, medical review, clinical monitoring, and safety reports to ensure quality and timely availability for customer needs. Ongoing support for In-Life Reports, Change Requests, and Incident Reports, ensuring they are fully documented, signed off, tracked, and reported to upper management, is also a key responsibility. Additionally, the Specialist will participate in extra activities such as study improvement task forces, automations, initiatives, new system testing, and ongoing training and mentoring.
Requirements
- B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant Pharma skills and experience.
- 4+ years’ experience in SQL, PL-SQL, PowerBI
- Expected to have a strong technical proficiency in a Clinical Data Management/Reporting Systems like Databricks, Python, SAS, etc along with AI related tools.
- Solid knowledge of MS Windows/Office 365 suit software and exposure to web-based applications.
- Solid knowledge of System Development Lifecycle Management / system validation knowledge
- Ability to establish and maintain good working relationships with different functional areas.
- Strong sense of urgency and customer focus.
- Possesses excellent communication skills and interacts effectively with Study Team.
- Strong organizational and problem-solving skills.
- Desire and ability to learn new processes and technologies
- Ability to multi-task, work independently, and good communication skills
- Understanding of drug discovery process, FDA regulations, GxP guidelines, ICH
Nice To Haves
- Adaptability
- Clinical Data Cleaning
- Clinical Data Management
- Customer-Focused
- Data Analysis
- Database Development
- Data Processing
- Data Quality Assurance
- Data Review
- Data Validation
- Data Visualization
- Electronic Data Capture (EDC)
- Learning Agility
- Pharmacovigilance
- PL/SQL (Programming Language)
Responsibilities
- Assume responsibilities for all clinical programming (including reporting and analytics) deliverables including Oracle, Veeva platforms along with the external data captured in support of the clinical studies.
- Coordinate and participate in the design, build, maintain, test, and document data review based on written specifications established by Global Clinical Data Management, Clinical Research and Global Safety.
- Review the technical feasibility of study team proposed programming/reporting and technically implement them.
- Work effectively among team to communicate issues and ideas to improve the business along with understanding of Protocol.
- Support the development & reporting for data cleaning, medical review, clinical monitoring, and safety reports for quality and timely availability in support of our customer needs.
- Perform ongoing support for In-Life Reports.
- Ensure Change Requests and Incident Reports are fully documented, signed off, tracked, and reported to upper management.
- Participate in extra activities including, but not limited to, study improvement task forces, automations, initiatives, testing of new systems, and ongoing training and mentoring.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
- annual bonus
- long-term incentive
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
