Associate Specialist, Clinical Data Management
About The Position
Primary activities include, but are not limited to: Assumes the 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. Coordinates and participates in the following activities: 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 implements 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. 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.
Requirements
- B.A. or B.S. degree, preferably in mathematics, science, a healthcare-related discipline, or computer science; or relevant Pharma skills and experience.
- Good technical proficiency in a Clinical Data Management/Reporting Systems like PowerBI or SQL/PL SQL or Databricks or Python or SAS, etc along with AI related tools.
- Solid knowledge of MS Windows/Office 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.
- Excellent communication skills and ability to interact 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
- Analytical Problem Solving
- Clinical Data Cleaning
- Clinical Data Management
- Clinical Medicine
- Clinical Physiology
- Clinical Reporting
- Clinical Research
- Computer Science
- Data Analysis
- Data Documentation
- Data Entry
- Data Processing
- Data Reporting
- Data Review
- Data Validation
- Data Visualization
- Drug Discovery Process
- FDA Regulations
- Good Clinical Practice (GCP)
- Medical Review
- Nephrology
- Pathophysiology
- Root Cause Analysis (RCA)
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, maintenance, testing, and documentation of 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 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
Entry Level
