Central Monitoring Manager

6 meses atrás

São Paulo, Brasil SAO Fortrea Brazil Limitada Tempo inteiro

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.

Job Summary

The Central Monitoring Manager has a critical role in ensuring full implementation of the risk plan and recommending appropriate changes to the ongoing monitoring. The Central Monitoring Manager collaborates within a matrix environment, communicates proactively internally and externally and across functions with key stake holders to ensure plans are proactively and effectively executed to meet client expectations The Central Monitoring Manager is expected to have a substantial working and industry knowledge of drug development and clinical trial execution. He/she is responsible for the preparation and conduct of central monitoring (Site, subject & study level review as applicable) activities on a series of sponsor projects or sponsor portfolio from proposal to study report. He/she conducts the central monitoring activities and recommends mitigations to project teams and oversees the findings at site, subject and study level.He/she provides the necessary support to the study team

Essencial Job Duties

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

Main requirements

University / college degree or post-graduation (life science preferred) from an appropriately accredited institution.

Minimum of 7-9 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.

Fluent English

End to End RBQM experience is preferred

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.

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