CluePoints provides Sponsors and CROs a better way of detecting and managing risks that may impact the outcome of clinical trials. Our solutions, all of which are underpinned by Central Statistical Monitoring, a technique that’s being investigated by the FDA for selecting sites for inspection, are deployed to drive a Risk-Based Quality Management strategy, as advocated by ICH and FDA.

This position will be required to interact with both English-speaking customers and Japanese-speaking customers. Flexibility in working hours will be expected as needed to support effective communication with customers in Japan.

Responsibilities

• Perform the technical configuration of the CluePoints solution for clinical studies based on customer requirements
• Perform analyses using the CluePoints Central Monitoring Platform – diagnosing and explaining anomalies identified in the clinical study data
• Summarize findings and support the communication of results to customers (both written report and oral presentation)
• 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 more senior Data Analysts and/or the CluePoints Project Manager as well as mentoring more junior Data Analysts as needed
• Ensure that appropriate documentation is produced and maintained for each study
• Support and participate in developing and improving training material used both internally and externally as well as providing both on-site and off-site training to customers
• And finally, assist Business Development and Quality Assurance teams in responding to client questions and requests (e.g., RFP responses, audits, etc.)

Skills Needed

• Experience with one or more programming languages, including SAS
• Experience with and understanding of clinical trials and clinical data
• Aptitude for mathematical and statistical concepts and data analytics
• Excellent oral and written communication skills: fluent in both Japanese and English (business level – oral and written communication)
• Experience and ability to work well in a team environment
• Ability to thrive in a fast-moving environment, under time and resource constraints
• High degree of accuracy and attention to detail
• Experience in delivery of technical solution trainings is a plus
• Experience with CDISC databases is a plus

Qualifications Needed

• College degree, preferably in a scientific or technical discipline
• 2+ years of experience in a clinical research environment
• Knowledge of industry regulatory and clinical data standards including 21 CFR Part 11, ICH E6 (GCP), CDISC standards, MedDRA, WHODRUG, etc.