Global Clinical Operations Specialist

hace 1 semana

Madrid, Madrid, España Fortrea A tiempo completo

At Fortrea, we're revolutionizing the development process to ensure the swift delivery of life-changing ideas and therapies to patients in need.

About the Role

This is a challenging opportunity for an experienced professional to join our team as a Global Clinical Operations Specialist. In this role, you will be accountable for execution and oversight of local operational clinical trial activities, with ownership, oversight, and impact on local regulatory and financial compliance at a country operations level.

The position has a significant impact on how a country can deliver country-specific trial commitments and objectives, especially during study start-up. The ability to indirectly influence investigators, vendors, external partners, and country managers to deliver these commitments is a must.

You will require skilled knowledge of budget and contract negotiations, the local ethics, legislation, and regulatory environment, submission and approval processes, development of local Informed Consent, as well as other site-ready and ongoing study deliverables.

Able to proactively develop risk management and mitigation plans in the country and resolve issues locally.

Responsibilities
  • Financial:
    • Assistance with the ownership of country and site budgets.
    • Through continual interaction with local clinical teams successfully delivers clinical and financial contracts within fair market value.
    • Oversight and tracking of clinical research-related payments.
    • Payment reconciliation at study close-out.
  • Country Submissions & Local Language Materials:
    • Responsible for execution and oversight of clinical trial country submissions and approvals for assigned protocols.
    • Development of local language materials including local language Informed Consents and translations.
    • Works in partnership with IRB/IEC and Regulatory Authority in submission and approval related interactions for assigned protocols.
  • Management & Quality Oversight:
    • Responsible for managing country deliverables, timelines, and results for assigned protocols to meet country commitments.
    • Contributes to the development of local SOPs.
  • Collaboration:
    • Works in close collaboration internally with Clinical Country Operations (CRD, CRM, CTC, CRA), Country Quality Manager (CQM), Finance, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Business Compliance, Legal, and regional operations, Headquarter functional areas, and externally with vendors and sites, IRB/IECs, and Regulatory Authorities to ensure country deliverables are obtained for submissions, budgets, CTRAs, and local milestones.
    • Collaborates closely with Regional Operations to align country timelines for assigned protocols. Provides support and oversight to local vendors as applicable.
  • Local Process Oversight:
    • Responsible for clinical and ancillary supplies management, importing and exporting requirements, supplies destruction, local electronic/hard copy filing, archiving, and retention requirements, and insurance process management.
    • Enters and updates country information in clinical, regulatory, safety, and finance systems.

Salary Range: $80,000 - $120,000 per year, depending on qualifications and experience.

We offer a comprehensive benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off.

Requirements
  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution, nursing certification, medical, or laboratory technology.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • In lieu of the above requirement, candidates with a minimum of four (4) or more years of relevant clinical research experience in pharmaceutical or CRO industries or experience in a healthcare setting will be considered.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.
  • Thorough knowledge of ICH Guidelines and GCP, including a basic understanding of regulatory requirements in other countries.
  • Thorough understanding of the drug development process.
  • Fluent in local office language and in English, both written and verbal.
  • Minimum of 2-3 years in the role.
  • Good organizational and time management skills.
  • Working knowledge of ICH, FDA, local regulatory requirements, IRB/IEC, and other applicable regulations/guidelines.
  • Familiarity with investigator start-up documents; previous interaction with operational project teams and investigative sites preferred.
  • Excellent communication skills, oral and written.
  • Self-motivation with the ability to work under pressure to meet deadlines.
  • Works well independently and in a team environment.
  • Detail and process-oriented.
  • Positive attitude and approach.
  • Interact with internal and external customers with a high degree of professionalism and discretion.
  • Multi-tasking capability.
  • Good computer skills with good working knowledge of a range of computer packages.
  • Ability to lead and develop junior staff.
  • Flexible and adaptable to a developing work environment.

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