Director of Site Management and Monitoring (DSMM)

The Director of Site Management and Monitoring (DSMM), in partnership with the Director of Clinical Site Operations (DCSO) is accountable for ensuring appropriate Site Care Partner (SCP), as well as Site Monitor resources are in place to deliver on, 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 and overseeing the job function of the Site Care Partner and Site Monitor.

The Director of Site Management and Monitoring supports the DCSO, who is accountable to ensure overall monitoring, operational site management and oversight activities within a designated country/cluster/region and supervises the monitoring, oversight activities of sites to ensure patient safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards.

This role 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 cluster when applicable. The role also executes investigator site/recruitment strategies and site-level end to end study start up, management and monitoring activities.

The Director of Site Management and Monitoring will lead, contribute to, and implement strategic initiatives as a representative of the GSSO Leadership. They will also lead initiatives that shape the clinical development environment within their country/cluster/region 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/network 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 Director of Site Management and Monitoring 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.

RESPONSIBILITIES:

Line Management of Site Care Partner roles and Site Monitors

• 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 function as described in the Site Care Partners & Line Manager of SCPs job description and ensure compliance with training requirements.
• Closely liaise with the FSP Manager of Site Care Partner as described in standard contracts with the FSP organization to oversee FSP SCP roles’.
• Oversee job function as described in the Site Monitors Job description and ensure compliance with training requirements
• Closely liaise with the FSP Manager of Site Monitors as described in standard contracts with the FSP organization to oversee FSP Site Monitor 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 solid investigator site relationships.
• Establish consistent direction and priorities across assigned countries/cluster/region.

Country/Cluster/Regional Environment & Across Site/Study Management (as delegated by the DCSO):

• 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 monitoring activities as performed by the selected Monitoring FSP or by partner CROs, safety and quality of sites in the country/cluster/region.
• Demonstrate Therapy Area expertise, where appropriate.
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