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Centralized Study Spec Ii

4+ years
Not Disclosed
10 Aug. 2, 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, 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

As a leading global contract research organization (CRO) with a commitment to scientific excellence and extensive experience in clinical development, Fortrea offers a broad range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas. With a dedicated team of over 19,000 professionals working in more than 90 countries, we are at the forefront of transforming drug and device development for our partners and patients worldwide.

Position Overview:

We are seeking a motivated and detail-oriented individual to join our team in a role that focuses on clinical study management and monitoring. In this position, you will be responsible for ensuring the high-quality execution of monitoring and reporting plans, supporting the implementation of new tools, and identifying opportunities for process improvements.

Key Responsibilities:

  • Adhere to all departmental Standard Operating Procedures (SOPs) and Work Instructions.
  • Execute high-quality monitoring and reporting plans, including specialized requests for approved protocols.
  • Support the implementation of new monitoring tools and track metrics as required by management.
  • Proactively identify and implement process improvements.
  • Mentor and train other team members as needed.
  • Manage clinical systems, study documents, and support eTMF management.
  • Assist study teams with data management queries and maintain study databases (CTMS, IWRS, EDC, etc.).
  • Track and follow up with CRAs on outstanding issues and support the generation of study-specific reports.
  • Manage internal and external communications, ensure training compliance, and handle study payments (site and vendor).
  • Review study performance dashboards and document study activities using relevant forms and tools.
  • Maintain Trial Master File documentation, participate in TMF QC, and manage project timelines and milestones.
  • Update the Xcellerate Risk Identification & Issue Resolution (XRIM) tool, addressing outstanding action items, including Protocol Deviations.
  • Draft or assist Functional Leads with project plans and coordinate reviews, feedback, and execution between the study team and client.
  • Facilitate study team communication, set up and document meetings, and manage vendor oversight as needed.

Qualifications:

  • Proven experience in clinical study management and monitoring.
  • Strong knowledge of clinical systems and databases.
  • Excellent organizational and communication skills.
  • Ability to mentor and train team members.
  • Proficiency with relevant project management tools and tracking systems.

Why Join Us:

Fortrea is dedicated to revolutionizing clinical trials and ensuring the rapid delivery of transformative therapies. By joining our team, you'll be part of a collaborative environment that fosters personal and professional growth, allowing you to make a significant global impact. For more information about Fortrea, visit www.fortrea.com.

Equal Opportunity Employer:

As an Equal Opportunity Employer, Fortrea is committed to fostering a diverse and inclusive workforce. We do not tolerate harassment or discrimination and make employment decisions based on business needs and individual qualifications, regardless of legally protected characteristics. We encourage all qualified individuals to apply.

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