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.
nPerforms the Central monitoring activities for multiple studies and ensure accurate tracking and status reporting of studies in his/her remit.
nManage portfolio of studies for a Customer and act as a customer point of contact
nCollaborates in the development Central Monitoring proposal text and review of costing, contributes to proposal strategy and development.
nCollaborates in the development of sponsor presentations/bid defense support.
nOversees at a study/customer level the appropriate tracking, interpretation and application of data to proactively manage risk
nEnsures that tracking and status reporting are performed in a timely and accurate manner. Applies data to recommend any required changes
nLeads, plans, prepares, conducts and follows up the central monitoring (Site, subject & study level review as applicable) activities and supports less experienced team members
nSupports PMO in preparation of initial Risk Management Register and may prepare, distribute and follow up Study Risk Impact Reports and coordinate Site Risk Weighting.
nEnsures Critical Data & Process Definition are implemented in EDC design by Data Expert
nConducts 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
nDevelops and establishes requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable Risk Factor trigger levels.
nDevelop the Central Monitoring and other applicable plans and any subsequent changes.
nManages 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
nPerforms 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
nAgrees potential changes to monitoring intervention level with project team in line with the applicable plans, and escalates appropriately.
nPerforms subject clinical reviews and take appropriate actions as applicable
nPerforms study analytics reviews as per the applicable plans and communicate the findings appropriately
nReviews and Approves changes to monitoring levels, ensuring compliance with applicable Plans and sponsor needs are met.
nOversees Project Quality and Risk Reports to ensure client satisfaction and compliance.
nCoaches assigned project teams internally and externally to increase the central monitoring competence.
nContributes to the development and maintenance of processes, including SOP writing, process mapping and process improvements using Six Sigma and LEAN methodologies.
nEvaluates and collates process improvement suggestions and submits to leadership.
nEvaluates and submits ideas and justification for improved systems and tools to leadership.
nAny other duties assigned by supervisor
nQualifications (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.
nExperience(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.
nFortrea 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.
nFortrea is proud to be an Equal Opportunity Employer:
nAs 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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