Are you passionate about risk based quality management in clinical trials?

Our client is an innovative, fast-growing company working in Risk-Based Monitoring, RBQM and Data Quality Oversight. Are you a data manager, data scientist interested in persuing a role as a Data Analyst?

We are seeking outstanding and experienced Clinical Data Analysts and Data Managers with a passion for delivering excellence to help drive customer success and broad adoption of our solutions. The Clinical Data Analyst is a key role in the team environment and needs to be able to communicate effectively. We need someone who will excel in a hardworking, creating, autonomous and team-oriented environment.

Key Duties/Responsibilities

• Perform the technical configuration of the solution for clinical studies based on customer requirements
• Perform analyses using the clients Central Monitoring Platform - diagnosing and explaining anomalies identified in the clinical study data
• Summarize findings and lead the communication of results to customers (both written report and oral presentation)
• Actively participate in the continuous improvement and development of our product solutions and operational processes
• Provide consultation and related operational support to customers as needed, with the help of Project Coordinator
• Ensure that appropriate documentation is produced and maintained for each study
• Provide mentoring to more junior Data Analysts as needed
• Support and participate in developing and improving training material used both internally and externally
• Provide both on-site and off-site training to customers
• Assist Business Development and Quality Assurance teams in responding to client questions and requests (e.g., RFP responses, audits, etc.)

Skills and Experience

• Strong experience in a clinical research environment
• Experience with one or more programming languages, SAS is a must
• Experience with and understanding of clinical trials and clinical data
• Demonstrated strong aptitude for data analytics, mathematical and statistical concepts
• Excellent oral and written communication skills in English
• Experience and ability to work well in a team environment
• Experience in delivery of technical solution trainings
• Ability to thrive in a fast-moving environment, under time and resource constraints
• High degree of accuracy and attention to detail
• College degree, preferably in a scientific or technical discipline
• Knowledge of industry regulatory and clinical data standards including 21 CFR Part 11, ICH E6 (GCP), CDISC standards, MedDRA, WHODRUG, etc.
• Experience with CDISC databases is a plus

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