Director, Site Management & Monitoring

About the role

The Director of Site Management and Monitoring (DSMM) is accountable for ensuring appropriate site management and monitoring resources 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. The DSMM supports the Director of Clinical Site Operations (DCSO) in ensuring overall site operations and site management and monitoring activities within designated countries/clusters/regions, and oversees requirements for sites to ensure participant safety and quality of study execution in accordance with applicable laws, Good Clinical Practice, and Pfizer standards.

Responsibilities

• Line Management of Site Management and Monitoring roles
• 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
• Perform joint site visits with direct reports to assess performance
• Establish consistent direction and priorities across assigned countries/cluster/region
• Country/Cluster/Regional Environment & Across Site/Study Management (as delegated by the DCSO)
• Ensure country level input into country selection, pre-feasibility, study design and site identification and selection
• Support and champion existing associated processes
• Ensure effective communication of feedback on country/site decisions to appropriate stakeholders
• Oversee operational delivery including 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
• Ensure timely and quality site start-up including activation
• Mitigate systematic deficiencies in clinical trial conduct across sites, to improve quality and participant safety in selected investigational sites
• Ensure sites with virtual monitoring and oversight capabilities are identified and enabled, as applicable
• Share country/cluster/regional issues and trends with stakeholders (e.g., study/program teams, local Medical Affairs teams, local CROs, Medical Quality Assurance, etc.), as needed
• Collaborate with local contract organizations (e.g., CRO) as needed to ensure overall delivery, quality, local regulatory and GCP compliance
• Build portfolio-aligned, investigational sites/site organization relationships and participate in local industry forums to shape performance of ethical clinical research, as needed
• Shape local clinical research environment by promoting GCP, ethics, regulatory process, and investigator training
• Contribute to Area and Global GSSO strategies by leading and participating in area or global initiatives
• Relationship Management
• Proactively manage the relationship with other functional lines within GSSO, e.g., study start-up (SUPM, CTA, SAP, ICL), regulatory/CTRO, Investigator Payment leads, OARS, Patient recruitment and study management to drive successful portfolio delivery in-country
• Proactively manage the country relationship with local external stakeholders (e.g., investigators, regulators, ethics committees, pharma associations, etc.)
• Develop relationships with the CROs/vendors locally in support of delivery of GSSO strategies
• Resource & Compliance Management
• Drive effective resource management across portfolio for designated countries/clusters/regions to ensure balanced resource allocation for Site Management and Monitoring roles across the Therapeutic Areas (TA) and regions
• Oversee and drive quality & compliance and goal related metrics for given country/ TA, including FSP management metrics
• Provide status updates in order to manage progress proactively as needed

Qualifications / Skills

• Education: Must be fluent in English. Local language capabilities are an advantage in this role. In general, candidates for this job would hold the following levels of education/ experience: BS/BSc/MS/MSc or equivalent and extensive clinical research experience, PhD/MD or equivalent and extensive clinical research experience
• Experience: Extensive knowledge (minimum 8 years) of clinical trial methodologies with proven ability to deliver high-quality clinical trial conduct obtained while working with a multi-national pharmaceutical company and/or clinical research organization
• Skills: Demonstrated People management experience, Ability to lead and manage diverse teams, Demonstrated ability to exhibit adaptive risk management and continuous learning capabilities, Ability to lead and influence a matrix environment, capable of driving initiatives across GSSO, Demonstrated understanding of People Experience (PX) procedure and policies at global and local level, Demonstrated ability to engage with senior stakeholders internally and externally to the organization, Ability to work effectively with line support functions including finance, PX across the region, Ability to both manage the resources required to deliver on organizational commitments and perform specific tasks of the roles managed, Ability to effectively coach and train direct reports including management of escalated issues from sites / investigators, and development of core competencies, Availability to travel within the region and/or globally as required, Agility to adapt to VUCA (Volatility, uncertainty, complexity and ambiguity)/evolving environment, Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact