Senior Regional Clinical Operations Director

Há 3 dias

São Paulo, São Paulo, Brasil beBeeClinical Tempo inteiro US$110.000 - US$135.000
Regional Clinical Study Senior Manager Job Description

We are seeking an experienced leader to spearhead our regional clinical operations team.

Key Responsibilities:
  • Effectively lead the regional clinical operations team, ensuring informed decision-making and resolving issues within the region.
  • Collaborate with key stakeholders in the region and provide regular updates on study progress to senior management and Global Clinical Study Manager as required.
  • Represent the regional study team at internal meetings and at cross-functional Clinical Study Team (CST) meetings.

The successful candidate will be accountable for regional study delivery with inspection readiness quality, within agreed timelines. They will also ensure alignment of regional deliverables with overall study goals and contribute to the development of regional tools.

Requirements:
  • Fluent English and Portuguese language skills, Spanish is a plus.
  • Strong leadership and communication skills.
  • Experience in pharmaceutical or biotech industry.
Study Management:

The Regional Clinical Study Senior Manager will lead planning and management of assigned clinical studies from feasibility through closeout activities for the region, in line with global study timelines. They will generate, manage, and maintain high-quality study start-up and recruitment timelines for the region and track progress towards these.

Quality Assurance:

The successful candidate will monitor study activities in the region to ensure compliance with study protocol, SOPs, ICH/GCP, and all other relevant regulations. They will also ensure inspection readiness for the study in the region at any point in time throughout the study life cycle.

Resource Allocation:

The Regional Clinical Study Senior Manager will work with the sourcing team to select and manage regional study vendors. They will also manage regional study budgets and work closely with Clinical Business Operation on investigator fees, site payment issues, and patient travel reimbursement activities.

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