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.
- Act as lead for a study and support the central monitoring teams on the delivery
- Support Manager in preparation of detailed study risk assessment and in Sponsor presentations / bid defenses.
- Ensures that tracking and status reporting are performed in a timely and accurate manner.
- Contributes to the Risk Assessment and Categorization Tool(RACT) for topics related to central Monitoring and/or medical reviews and considers risks when planning tools configuration
- Supports the Data Expert with Critical Data and Process Definition and EDC design implementation
- Supports the development of informatics Platform requirements, including design of the visualizations, taking into consideration the data feeds for the study (EDC, laboratory, etc.)
- Collates requirements including prescriptive risk factor mitigation strategies, SDV strategy, study-specific risk factor definition, variable risk factor trigger levels.
- Draft the Configuration Plan and all other applicable Plans in collaboration with the study team and update these on an ongoing basis including the refinement of visualizations and any edits in line with emerging risk profile and study changes.
- Edits the Central Monitoring and other applicable plans in line with emerging risk profile and study changes.
- Populates the tools, tests variable risk factors, adjusts trigger levels, study specific risk factors and central monitoring parameters.
- Performs ongoing reviews, prepares and recommends mitigation actions and reviews recommended monitoring levels with project team and ensures that identified issues are followed to resolution
- Proposes potential changes to monitoring intervention level on behalf of the project team in line with overall strategies
- Prepares and distributes the Project/Study Reports at intervals during study conduct and at study close out.
- Undertakes Central Monitoring (Site, subject & study level review as applicable) activities to ensure consistency and effectiveness.
- Take responsibility for inspection readiness for activities; support regulatory authority inspections when needed
Qualifications (Minimum Required)
:
- University / college degree (life science preferred) from an appropriately accredited institution.
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
- Good ability to work with/ to present to peers and junior level staff.
- Good analytical skills, strong detail focus and accuracy.
- Good planning, time management and organizational skills
- Some influencing, negotiation and problem solving skills.
- Some project and risk management skills.
Experience (Minimum Required):
- Minimum of 5-7 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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