Director Site Management and Monitoring

Use Your Power for Purpose
We are seeking a strategic and experienced Director of Site Management and Monitoring to join our Global Site and Study Operations (GSSO) team. In this pivotal leadership role, you will support the Senior Director of Clinical Site Operations to ensure the appropriate resourcing and execution of end-to-end site startup and monitoring activities across designated countries and clusters.
As a seasoned people leader, you will provide effective line management, foster cross-functional collaboration, and drive the implementation of country-level strategies. You will also play a key role in shaping and delivering strategic initiatives as a recognized GSSO leader and subject matter expert in site management.
If you are passionate about advancing clinical operations through strong leadership, operational excellence, and cross-functional partnership, we invite you to join our mission to bring breakthroughs that change patients' lives.
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.

• 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.

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 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.
• Responsible for 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.
• Working within the directions of a global and regional strategies, 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.
• When required, contribute to Area and Global GSSO strategies 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, 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

• Driving 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.

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.

Work Location Assignment: Hybrid /Sydney Head office
At Pfizer we care about our colleagues' wellbeing and offer a range of great benefits for them, including:

• Paid parental leave
• Access to Health & Wellness apps
• Career Growth Experiences program
• Recognition & rewards program
• Paid volunteer days
• Life Insurance Benefits
• Pfizer Learning Academy access to top content providers
• Access to flu vaccines & skin checks
• Options to purchase additional leave
• Salary packaging & novated lease options

*Benefits listed may vary depending on your position and location and may be subject to change.
Pfizer Australia and New Zealand's diverse workforce represents the patients we serve and the communities in which we operate. With a focus on Diversity, Equity & Inclusion (DE&I), Pfizer ANZ ensures our people are heard and cared for. We offer engagement opportunities in both Colleagues Resource Groups (CRGs) and workstreams across: Culture and Tradition, Reconciliation @ Pfizer (RAP), Gender Equity (GEN), Disability and through the Out Pfizer Employee Network (OPEN) for our LGBT + colleagues and allies.
If you require reasonable adjustment during your application, please reach out to the Talent Acquisition Manager.
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