CLINICAL OPERATIONS DIRECTOR

Job Description This role based in Mexico will be key to further develop the country capabilities in clinical research.
Under the oversight of the country CRD the person will be responsible for the end to end performance of clinical trials in one or several TA, from feasibility to close out in one or several countries.
The role should be responsible for 30 to 50 clinical trials and will ensure excellent study performance with strict adherence to local regulations, SOPs and ICH GCP.
The role is responsible for oversight of all the employees working in the TA, with line management for CRMs and functional oversight of other roles in his studies.
As line manager the role is critical to develop key talents in the organization to ensure a pool of successors in critical roles.
The role will work at country level with other local stakeholder like GMA, GHH, PV and regulatory to ensure alignment and development of the country capabilities and can represent the CRD of cluster in local management if required.
CRD can delegate certain key tasks as needed.
Responsibilities include, but are not limited to.
• Will lead 1 or several TA of the growing portfolio in the country • Accountable for the successful execution, enrollment and quality of their clinical trial portfolio • Accountable to ensure timelines and key milestones are met • Accountable for performance metrics • Accountable to develop operational strategies and quality plans for the conduct of all  programs and studies in the TA portfolio • Collaborates with other TA directors, local and regional stakeholder in GCTO in order to  develop and build territory of principal investigators and sites • Ensures oversight and line management of Clinical Research Manager (CRM) team within  TA • Leads team independently with supervision from CRD to high performance • Accountable for CRM performance reviews, including addressing low performance situations, and taking appropriate actions.
• Ensures key talent development and retention • Collaborates and works closely with other stakeholders in the TA in GCTO & GCD regional and headquarter teams, quality, finance, IT and HR • Collaborates 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.
• Together with direct reports contributes significantly to effective conduct of clinical studies  and to develop the pipeline, while maintaining regulatory requirements and compliance  • This position impacts directly the country´s ability to reach business targets and objectives  and ensures that productive collaboration with internal and external business partners are built.
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Employee Status.
Regular Relocation.
VISA Sponsorship.
Travel Requirements.
Flexible Work Arrangements.
Hybrid Shift.
Valid Driving License.
Hazardous Material(s).
Job Posting End Date.
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Requisition ID.
R