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Centralized Study Spec Ii

2-4 years
Not Disclosed
10 Aug. 6, 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

Join Fortrea: Transforming Clinical Development Globally

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 with 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 worldwide.

Key Responsibilities

  • Adherence to Procedures: Follow all applicable departmental Standard Operating Procedures (SOPs) and Work Instructions.
  • Monitoring and Reporting: Execute high-quality, timely monitoring and reporting plans, including specialized monitoring requests for approved protocols.
  • Implementation Support: Assist in the implementation of new monitoring tools.
  • Metrics Tracking: Track and report metrics as determined by management within required timelines.
  • Process Improvement: Proactively identify opportunities for process improvements and participate in their implementation.
  • Mentoring: Mentor and train other team members.
  • Study Management: Manage clinical systems, study documents, and support eTMF management.
  • Data Management: Support study teams to resolve data management queries and maintain study databases (CTMS, IWRS, EDC, etc.).
  • Issue Tracking: Track and follow up with CRAs for outstanding issues.
  • Reporting: Support in generating study-specific reports.
  • Communication: Manage internal/external communications and assist in ensuring training compliance for study teams.
  • Payments Management: Manage study payments (Site and Vendor) – including payment reconciliation and release.
  • Performance Review: Review study performance dashboards.
  • Documentation: Document and track study activities using relevant forms and tools, as well as relevant Project Management Systems.
  • Compliance: Actively support compliance metrics including TMF, CTMS, and overall project health.
  • Timeline Management: Update timelines and milestones within project scheduling tools and escalate when timelines are at risk.
  • Risk Management: Update the Xcellerate Risk Identification & Issue Resolution (XRIM) tool and follow up on outstanding action items to resolution, including Protocol Deviations.
  • Project Planning: Draft or assist Functional Leads with project plans and coordinate review, feedback, and execution between the study team and client.
  • Cross-Functional Tasks: Assist with additional cross-functional tasks according to project needs.

Additional Responsibilities (Centralized Study Team Activities)

  • Team Collaboration: Facilitate study team communication and collaboration by attending and setting up team meetings for all functions.
  • Meeting Documentation: Facilitate and document meetings using relevant tools, ensuring they are distributed and documented according to study requirements.
  • Vendor Oversight: Manage vendor oversight and ensure effective communication and problem resolution.

Why Join Fortrea?

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.

Equal Opportunity Employment

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 on 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.

For more information about how we collect and store your personal data, please see our Privacy Statement.

Join Fortrea and make a difference in global healthcare.