Risk and Central Monitoring Associate Manager

Worldwide Clinical Trials; Durham (NC); À distance; USD 66 000 - 131 000; Plein temps

Avantages offerts par ce poste

Remote work

Competitive benefits

Résumé du poste

Worldwide Clinical Trials is seeking a Risk and Central Monitoring Associate Manager to lead RBQM activities across clinical studies. You will develop central monitoring plans, support risk assessments, and collaborate with cross-functional teams to ensure risk-based quality management throughout the trial lifecycle.

Remote role open to US or Europe candidates, with an emphasis on RBQM expertise, data-driven inspection readiness, and effective communication with sponsors and study teams.

Qualifications

• Experience applying RBQM principles in clinical trials.
• Ability to analyze complex study data, identify trends and risks.
• Collaborate across global teams and functions.
• Strong communication and presentation skills.
• Proficient with Microsoft Office and clinical tech systems.

Responsabilités

• Lead RBQM activities for assigned clinical studies.
• Develop and maintain Central Monitoring Plans and align with strategies.
• Support risk assessments with cross-functional teams.
• Track KRIs and QTLs and monitor indicators.
• Perform centralized monitoring reviews to identify trends and risks.
• Maintain dashboards and support ongoing monitoring throughout studies.
• Deliver RBQM training and guidance to study teams.
• Support inspection readiness, budgets, sponsor interactions, and audits.

Connaissances

RBQM knowledge

Data analysis

Cross-functional collaboration

English proficiency

Microsoft Office

Formation

BSc, RN, or equivalent

Description du poste

Who we are

We're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs - in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day. Join us!

Make an Impact as a Risk and Central Monitoring Associate Manager at Worldwide

Help drive quality and oversight across clinical trials by supporting risk management and central monitoring activities that are critical to study success. In this role, you'll work with cross-functional teams to identify, assess, and monitor study risks while helping ensure trials are conducted in accordance with ICH GCP guidelines.

You'll play an important role in advancing Risk-Based Quality Management (RBQM) strategies, supporting study teams with risk assessments, centralized monitoring activities, and data-driven insights that help maintain quality throughout the clinical trial lifecycle.

Working closely with internal stakeholders and sponsors, you'll contribute to consistent, inspection-ready processes while helping teams focus on what matters most: delivering high-quality clinical research that supports better outcomes for patients.

Where You'll Work

This is a REMOTE role open to candidates based in US or Europe. You will collaborate with global teams across multiple time zones.

What You'll Do

• Lead and oversee Risk-Based Quality Management (RBQM) activities for assigned clinical studies.
• Develop and maintain Central Monitoring Plans, ensuring appropriate approvals and alignment with study strategies.
• Support the creation and ongoing review of study risk assessments, partnering with cross-functional teams to identify and evaluate risks.
• Facilitate the identification, tracking, and monitoring of Key Risk Indicators (KRIs) and Quality Tolerance Limits (QTLs).
• Perform centralized monitoring reviews to identify trends, outliers, signals, and potential risks, recommending actions to study teams.
• Maintain central monitoring dashboards and support ongoing monitoring activities throughout the study lifecycle.
• Deliver training and guidance to study teams on RBQM strategies, monitoring approaches, and risk management processes.
• Contribute to inspection readiness activities, budget awareness, sponsor interactions, audits, and other project-related meetings.

What You'll Bring

• BSc, RN, or an equivalent combination of education, skills, and experience.
• At least 4 years of clinical research experience, including a minimum of 3 years of experience with Risk-Based Monitoring (RBM) and associated ICH/regulatory guidance.
• Prior experience working as a Central Monitor or within a Central Monitoring function.
• Strong understanding of RBQM principles, study risk assessments, centralized monitoring, KRIs, and QTLs.
• Demonstrated ability to analyze complex data, identify trends and risks, and apply critical thinking to problem-solving and issue resolution.
• Experience collaborating across functions and working effectively within global project teams.
• Strong communication, presentation, planning, and organizational skills.
• Proficiency in English and strong proficiency with Microsoft Office and clinical technology systems.

At Worldwide Clinical Trials, we are committed to fostering an inclusive and equitable workplace by providing transparent compensation.

The salary range for this position is annually (For hourly paid positions, the stated salary range reflects hourly rates):

United States of America - $65,500.00 - $130,500.00

The salary range provided is intended to give candidates an understanding of potential earnings. Compensation will fall within the provided range, and it not a guarantee of exact salary. The final salary will be determined based on relevant experience, performance, education, and internal equity. In addition to base salary, we offer a competitive benefits package depending on location. We ensure pay equity and transparency and comply with all applicable labor laws. Salary information will be discussed during the interview process, and we encourage candidates to inquire about compensation at any stage.

We love knowing that someone is going to have a better life because of the work we do.