Senior Clinical Data Analyst – Bilingual Japanese (US)
King of Prussia,
CluePoints is an innovative, fast-growing company and the premier provider of Risk-Based Monitoring and Data Quality Oversight solutions to clinical research organizations. Our products enable both risk planning and operational risk monitoring, and utilize advanced statistical algorithms to determine the quality of clinical trial data both during and following study execution. CluePoints is seeking outstanding candidates with strong data analytics aptitude and a passion for delivering excellence, to help drive customer success and broad adoption of the CluePoints solution.
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.
- 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 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.)
- 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 with CDISC databases is a plus
- College degree, preferably in a scientific or technical discipline
- 5+ 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.
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