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Central Monitoring Lead

5-7 years
Not Disclosed
10 Sept. 23, 2024
Job Description
Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

About Fortrea

Fortrea is a leading global contract research organization (CRO) dedicated to scientific rigor and driven by decades of clinical development expertise. We provide pharmaceutical, biotechnology, and medical device clients with a comprehensive range of clinical development, patient access, and technology solutions across over 20 therapeutic areas. With a workforce of over 19,000 professionals operating in more than 90 countries, Fortrea is transforming drug and device development for partners and patients worldwide.


Job Summary

As a Central Monitoring Lead, you will oversee central monitoring activities for multiple studies, ensuring accurate tracking and status reporting. You will support the central monitoring teams in delivering high-quality results and assist the Manager in preparing detailed study risk assessments and sponsor presentations.


Key Responsibilities

  • Central Monitoring Activities:
    Lead central monitoring for multiple studies, ensuring timely and accurate tracking and reporting.

  • Study Leadership:
    Act as the lead for specific studies and provide support to central monitoring teams.

  • Risk Assessment:
    Collaborate with the Manager on detailed risk assessments and sponsor presentations.

  • RACT Contributions:
    Contribute to the Risk Assessment and Categorization Tool (RACT), addressing central monitoring and medical review topics.

  • Data Expert Support:
    Assist the Data Expert in defining critical data and processes, as well as in EDC design implementation.

  • Informatics Platform Development:
    Support the development of informatics platform requirements, including visualization design, considering various data feeds (EDC, laboratory, etc.).

  • Requirements Collation:
    Gather requirements for risk factor mitigation strategies, SDV strategies, and study-specific risk factors.

  • Configuration Plan Drafting:
    Draft and continually update the Configuration Plan and other applicable plans in collaboration with the study team.

  • Tool Management:
    Populate tools, test variable risk factors, and adjust trigger levels as needed.

  • Ongoing Reviews:
    Conduct regular reviews, recommend mitigation actions, and ensure project issues are resolved.

  • Monitoring Intervention Proposals:
    Suggest changes to monitoring intervention levels in alignment with project strategies.

  • Reporting:
    Prepare and distribute Project/Study Reports at various intervals throughout the study and at closeout.

  • Inspection Readiness:
    Ensure readiness for inspections and support regulatory authority inspections as necessary.


Qualifications

Education:

  • University or college degree in a life science field (preferred). Fortrea may consider relevant experience in lieu of formal education.

Skills:

  • Ability to present and collaborate effectively with peers and junior staff.
  • Strong analytical skills with a keen attention to detail.
  • Excellent planning, time management, and organizational skills.
  • Basic influencing, negotiation, and problem-solving skills.
  • Familiarity with project and risk management.

Experience

  • 5-7 years of relevant clinical research experience in a pharmaceutical company, CRO, or similar roles, with increasing responsibilities in project management, clinical monitoring, data management, or informatics.

Join Us

Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our commitment to overcoming challenges in clinical trials. We strive to revolutionize the development process, ensuring the swift delivery of life-changing therapies to patients in need. Join our exceptional team and thrive in a collaborative environment that nurtures personal growth and enables you to make a meaningful global impact. For more information, visit www.fortrea.com.


Equal Opportunity Employer

Fortrea is proud to be an Equal Opportunity Employer. We are committed to diversity and inclusion in the workforce and do not tolerate harassment or discrimination of any kind. Employment decisions are based on business needs and individual qualifications, without regard to race, religion, gender, sexual orientation, disability, or any other legally protected characteristic. We encourage all qualified candidates to apply.