Joule is seeking a Senior Central Monitor to join a collaborative and innovative team for a 6-month contract. This role offers a unique opportunity to contribute to centralized monitoring and risk-based monitoring (RBM) activities in clinical trials. As a key member of the team, you will play a critical role in ensuring data quality, patient safety, and efficient trial execution while working closely with cross-functional teams to assess and mitigate risks. If you are detail-oriented, adept at managing data, and passionate about clinical research, this position is an excellent fit for you.
Develop and review study metrics, triggers, KRIs, and other monitoring tools to identify and mitigate risks in clinical trials.
Collaborate with cross-functional teams to implement and review centralized monitoring outputs, ensuring data quality and patient safety.
Set up and test study data integration with RBM systems to support key monitoring processes, including statistical analyses and root cause investigations.
Communicate findings and monitoring observations to study teams, leading discussions and coordinating with appropriate partners.
Ensure compliance with regulatory requirements (FDA, ICH, GCP) and align RBM implementation with data access plans.
Demonstrate expertise in data management, statistical tools (SAS, R, Python), and clinical research processes, while managing multiple projects effectively.
Bachelor’s degree in life science, data science, statistics, or mathematics; Master’s degree preferred.
Minimum of 5+ years of experience in data management or RBQM activities.
Proficiency in statistical programming languages and Microsoft Office tools.
Strong interpersonal and communication skills with the ability to work independently and collaboratively.
Knowledge of clinical research and regulatory guidelines, including FDA, ICH, GCP, and GCDMP.
Ability to manage priorities in a fast-paced environment and deliver high-quality results on time.
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