Description

Central Monitor II (RBQM / KRI review Exp)

Syneos Health® is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.

Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.

Discover what your 25,000 future colleagues already know:

Why Syneos Health
. We are passionate about developing our people, through career development and progression supportive and engaged line management technical and therapeutic area training peer recognition and total rewards program.
. We are committed to building an inclusive culture - where you can authentically be yourself. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
. We are continuously building the company we all want to work for and our customers want to work with. Why Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Should have minimum 2yrs of relevant CM experience
Willing to work extensively in RBQM‑driven processes.
Experience in reviewing KRIs preferred
EMEA timing
Cluepoints Experience preferable
Supports the Central Monitoring Lead in the study-specific set-up and ongoing maintenance of the data analytical tool used for centralized monitoring
RBM data analytical tool expert for conducting data risk review, risk and issue management
Participates in the training of central and local study teams on RBQM and central monitoring processes
Performs centralized monitoring of study data and maintains oversight of study/country/site risk parameters according to the study monitoring plan
Identifies data quality trends indicative of systematic errors and potential study/country/site performance issues
Communicates to relevant study team members trends/findings,implications and recommends actionswithin data analytical tool and provides regular status reports to study team
Ensures the proper documentation & archiving of instream data reviews, risk and issue management
Shares the responsibility for data quality at the study, country and site levels

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you'll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

Summary

To support the implementation of Risk Based Quality Management (RBQM) across studies, focus on Centralized Monitoring (CM) and Data analytics (DA) to ensure consistent application of RBM principles. From study start through to study Data Base Freeze, conducts holistic and centralized review of study data according to the study Monitoring Plan, uses data analytical tools to identify emerging and existing risks to critical study data and process. Enables proactive identification, communication, escalation and management of risks at the study/country/site level.