Directeur Site Management et Monitoring (F/M)

ROLE

• The Director of Site Management and Monitoring (DSMM), in partnership with the Director of Clinical Site Operations (DCSO), is accountable for ensuring appropriate site management and monitoring resources (e.g., Site Care Partner (SCP), Clinical Research Associate (CRA), Site Monitor) are in place to deliver on both country and site-level end-to-end study start-up, management and monitoring activities in line with study milestones in the designated countries/clusters/regions, as well as providing line management, overseeing the job function of the roles.
• The DSMM supports the DCSO, who is accountable to ensure overall site operations and site management and monitoring activities within designated countries/clusters/regions and supervises requirements for sites to ensure participant safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards.
• The DSMM partners cross-functionally with others in Study Start-Up (Start-Up Project Management (SUPM), Site Activation Partner (SAP), Clinical Trial Assistant (CTA), Investigator Contracts Lead (ICL)), Optimization, Analytics, and Recruitment Solutions (OARS), Patient Recruitment and Study Management to provide input to country and site selection and collaborate with country regulatory/regional Clinical Trial Regulatory Operations (CTRO) to facilitate Clinical Trial Application/IRB/EC approval for allocated studies in their designated countries/clusters/regions, when applicable. The role also executes investigator site/recruitment strategies and site-level end to end study start-up, management and monitoring activities.
• The DSMM will lead, contribute to, and implement strategic initiatives as a representative of GSSO Leadership. They will also lead initiatives that shape the clinical development environment within designated countries/clusters/regions to facilitate Pfizer’s clinical development goals and scientific leadership. For example, this role actively manages risks and identifies opportunities for clinical trial conduct through engagement with local clinical development leaders and/or regulatory authorities, actively participates in local industry forums, builds portfolio-aligned, investigational sites/site organization relationships to shape performance of ethical clinical research, as needed (e.g., Decentralized Clinical Trial (DCT) readiness, virtual monitoring, and drive the cycle times reduction).
• The DSMM may be aligned with assets within Therapeutic Areas to serve as a strategic point of contact for items such as planning, quality events, inspections. The DSMM may be aligned to a centralized service (e.g., informed consent processing) to serve as a strategic point of contact / lead for items such as planning and delivery.
• The DSMM provides insights on local/regional trends to facilitate the conduct of clinical trials and, where appropriate, is responsible for developing analyses and offering options for mitigation (both at the country/cluster and site level) on the trial’s conduct.

JOB RESPONSIBILITIES

• Lead and coach allocated resources within assigned country/cluster/region.
• Overall accountability for the Growth and Development of the Site Operations organization (Individual Contributors)
• Oversee job functions as described in the relevant job descriptions, and ensure compliance with training requirements.
• Closely liaise with the FSP Managers of Site Management and Monitoring roles, as described in standard contracts with the FSP organizations to oversee FSP roles.
• Where required, perform joint site visits with direct reports to assess performance.
• Demonstrate leadership in the resolution of site/country/cluster/regional issues to maintain site start-up, quality and strong investigator site relationships.
• Establish consistent direction and priorities across assigned countries/cluster/region.
• Responsible for country level input into country selection, pre-feasibility, study design and site identification and selection; when necessary, support and champion existing associated processes. Ensure that feedback on country/site decisions is effectively communicated to appropriate stakeholders.
• Responsible for the oversight of the operational delivery including the site management and monitoring activities as performed by the selected FSPs or by partner CROs, safety and quality of sites in the country/cluster/region.
• Demonstrate Therapeutic Area expertise, where appropriate.
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