San Rafael, California, USA
4 days ago
Senior Central Monitor

Job Title: Senior Central Monitor Location remote Hours/Schedule: Monday - Friday Compensation: $35-40/hr Overview

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.

Responsibilities

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.

Requirements

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.

System One, and its subsidiaries including Joulé, ALTA IT Services, TeamPeople, and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.


System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.


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