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.
• Responsible for timely and quality site start-up including activation.
• Mitigate systematic deficiencies in clinical trial conduct across sites, to improve quality and patient 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.
• Working within the directions of a global strategy, build portfolio-aligned, investigational sites/network 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.
• When required, contribute to area or global GSSO strategy by leading and participating in area or global initiatives.

Relationship Management

• Ensure a proactive relationship is maintained between GSSO colleagues and other in-country functional lines such as regulatory, safety and medical affairs.
• Proactively manage the relationship with other functional lines within GSSO/PRD e.g., study start-up (SUPM, CTA, SAP, ICL,), regulatory/CTRO, Investigator Payment leads, OAQS, 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

• Driving effective resource management across portfolio for given country to ensure balanced resource allocation for SCP and site monitors 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:

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 10 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.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Minimal travel required

Work Location Assignment:Remote

#LI-REMOTE

#LI-PFE

The annual base salary for this position ranges from $149,200.00 to $248,600.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life’s moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site – U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa, FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

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