Clinical Operations Director
hace 4 días
This role is pivotal in driving the expansion of clinical research capabilities in Mexico, working under the oversight of the country Clinical Research Director (CRD). As a key member of the country leadership team, you will be responsible for overseeing the end-to-end performance of clinical trials across various therapeutic areas, from feasibility to close-out.
The successful candidate will lead a portfolio of 30-50 clinical trials, ensuring excellent study performance by adhering to local regulations, SOPs, and ICH GCP. You will also oversee all employees working in the therapeutic area, providing line management for Clinical Research Managers (CRMs) and functional oversight of other roles.
As a leader, you will be critical in developing key talents within the organization, ensuring a pool of successors in critical roles. You will collaborate with local stakeholders, such as GMA, GHH, PV, and regulatory bodies, to ensure alignment and development of country capabilities.
Key Responsibilities:
- Lead one or several therapeutic areas of the growing portfolio in Mexico.
- Accountable for the successful execution, enrollment, and quality of their clinical trial portfolio.
- Ensure timelines and key milestones are met, with accountability for performance metrics.
- Develop operational strategies and quality plans for the conduct of all programs and studies in the TA portfolio.
- Collaborate with other TA directors, local and regional stakeholders in GCTO to develop and build territory of principal investigators and sites.
- Oversight and line management of CRM team within TA.
- Leads team independently with supervision from CRD to high performance.
- Accountable for CRM performance reviews, addressing low performance situations, and taking appropriate actions.
- Ensure key talent development and retention.
- Collaborate and work closely with other stakeholders in the TA in GCTO & GCD regional and headquarter teams, quality, finance, IT, and HR.
- Collaborate externally with investigators, regulators, and vendors.
- Member of the GCTO country leadership team.
- Supports strategic initiatives across Global Clinical Development GCD and GCTO.
- Supports local strategy development consistent with long-term corporate needs in conjunction with CRD.
- Contributes significantly to effective conduct of clinical studies and develops the pipeline while maintaining regulatory requirements and compliance.
This position directly impacts the country's ability to reach business targets and objectives, ensuring productive collaboration with internal and external business partners.
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