Regional Clinical Operations Manager

Há 2 dias

São Paulo, São Paulo, Brasil beBeeClinical Tempo inteiro R$733.440 - R$1.031.180

Senior Clinical Research Leader

We are seeking a Senior Clinical Research Leader to oversee the delivery of regional clinical studies with high-quality inspection readiness within agreed timelines and budget.

This role involves acting as a regional lead for multiple studies across an indication or across a program, leading the regional clinical operations team (including external partners working on a regional level) and acting as the point of escalation for the resolution of issues within the region for the assigned study.

Key Responsibilities
  • Lead the regional clinical operations team effectively, ensure effective decision-making and act as a point of escalation for the resolution of issues within the region for the assigned study.
  • Collaborate with key stakeholders in the region and provide regular updates on study progress in the region to senior management and Global Clinical Study Manager as required.
  • Monitor study activities in the region to ensure compliance with the study protocol, SOPs, ICH/GCP and all other relevant regulations.
  • Ensure inspection readiness for the study in the region at any point in time throughout the study life cycle.
  • Prepare sites for quality assurance audits and inspections, drive responses to audit and inspection findings as appropriate.
  • Develop and maintain high-quality study start-up and recruitment timelines for the region and track progress towards these.
  • Work closely with Clinical Business Operation on investigator fees, site payment issues and patient travel reimbursement activities.
  • Identify and manage regional team resource needs and establish contingency plans for key resources.
  • Review and sign-off monitoring reports and contribute to the development of regional tools and lead to the development of work instructions and SOPs as required.
Requirements
  • A Bachelor's degree or higher in a scientific or healthcare discipline preferred with a minimum of 7 or more years of progressive experience in clinical research within biotech, pharma or CRO industry.
  • A minimum of 1-3 years of relevant clinical operations experience.
  • Proven experience in clinical research including relevant experience as team lead in clinical functions.
  • Experience as CRA is preferred.
Benefits

This role offers opportunities for career growth and development, a dynamic work environment, and a competitive compensation package.

The ideal candidate will be highly motivated, collaborative, and have a passion for fighting cancer.

Others

We are proud to be an equal opportunity employer and welcome applications from diverse candidates.

Please submit your resume/CV for consideration.

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