As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

• Performs the Central monitoring activities for multiple studies and ensure accurate tracking and status reporting of studies in his/her remit.

• Manage portfolio of studies for a Customer and act as a customer point of contact

• Collaborates in the development Central Monitoring proposal text and review of costing, contributes to proposal strategy and development.

• Collaborates in the development of sponsor presentations/bid defense support.

• Oversees at a study/customer level the appropriate tracking, interpretation and application of data to proactively manage risk

• Ensures that tracking and status reporting are performed in a timely and accurate manner. Applies data to recommend any required changes

• Leads, plans, prepares, conducts and follows up the central monitoring (Site, subject & study level review as applicable) activities and supports less experienced team members

• Supports PMO in preparation of initial Risk Management Register and may prepare, distribute and follow up Study Risk Impact Reports and coordinate Site Risk Weighting.

• Ensures Critical Data & Process Definition are implemented in EDC design by Data Expert

• Conducts Site Risk Assessment across multiple studies, works with study start up team members, reviews site outreach, Pre-Study Visit reports and Site Risk Assessment. Prepares site risk stratifications and proposes baseline site risk levels and initial site monitoring intervention levels

• Develops and establishes requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable Risk Factor trigger levels.

• Develop the Central Monitoring and other applicable plans and any subsequent changes.

• Manages configuration of tools, risk factors trigger levels, programming of study specific risk factors and central monitoring parameters and performs user acceptance testing of applicable tools

• Performs ongoing dashboard reviews, prepares and recommends mitigation actions and reviews recommended monitoring levels with project team and ensures that identified issues are followed to resolution

• Agrees potential changes to monitoring intervention level with project team in line with the applicable plans, and escalates appropriately.

• Performs subject clinical reviews and take appropriate actions as applicable

• Performs study analytics reviews as per the applicable plans and communicate the findings appropriately

• Reviews and Approves changes to monitoring levels, ensuring compliance with applicable Plans and sponsor needs are met.

• Oversees Project Quality and Risk Reports to ensure client satisfaction and compliance.

• Coaches assigned project teams internally and externally to increase the central monitoring competence. 

• Contributes to the development and maintenance of processes, including SOP writing, process mapping and process improvements using Six Sigma and LEAN methodologies.

• Evaluates and collates process improvement suggestions and submits to leadership.

• Evaluates and submits ideas and justification for improved systems and tools to leadership.

• Any other duties assigned by supervisor

Qualifications (Minimum Required):

•University / college degree or post-graduation from an appropriately accredited institution.

•Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience(Minimum Required):

•Minimum of 10+ years of relevant clinical research experience in a pharmaceutical company/CRO or other equivalent experience with increasing levels of responsibility in clinical trial related roles e.g., project management, clinical monitoring, data management and informatics.

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.

Fortrea is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.

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