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 pursuing a role as a Senior Clinical Data Analyst?

We are seeking outstanding and experienced Senior Clinical Data Analysts and Data Managers with a passion for delivering excellence to help drive customer success and broad adoption of our solutions. The Senior 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.

Responsibilities

Perform the technical configuration of the clients 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)

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 other Data Analysts

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 Needed

Experience with one or more programming languages, including SAS

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

Experience with CDISC databases is a plus

Qualifications Needed

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.

*You have to have Clinical trial and SAS experience*

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