Regional Operations Lead (ROL)

• Partner with the Head of Site Operations and DCSOs in assigned regions, and as a member of the regional leadership team, to shape and help drive regional strategies and contribute to global clinical development goals. Cross-functional collaboration with key roles such as OARs.
• Partner with Asset Directors of Study Management (DSMs) and Clinical Study Group Leads at TA project review meetings and asset meetings to represent Site Operations within region, ensure input is given to discussions impacting Site Operations resources and processes, and share critical operation information to Head of Regional Site Operations and DCSOs.
• Be an active contributor in CEPOC and POP, Feasibility Alignment Meetings, Country Strategy Meetings etc to support country selection aligned with regional strategies and global business goals
• Close partnership with Regional Head of Site Operations to ensure trial allocation objectives are met.
• Identify opportunities for operational excellence or process improvement at a regional level and align globally with key stakeholders, including Process and Standards Leads group.

• Oversee effective end-to-end resource planning and allocation across portfolio for designated regions to ensure balanced resource allocation for Site Management and Monitoring roles.
• Partner with Strategic Operations Resource Specialists, Asset DSMs, DCSOs and functional managers to forecast staffing needs based on pipeline and ongoing studies.
• Monitor resource utilization, availability, and workload balance to maximise efficiency and avoid over- or under-allocation.
• Lead regional resource meetings and maintain accurate up-to-date records in relevant systems (eg. Resource management tools, spreadsheets, databases).

• Develop, manage, and track regional project portfolio and track goals. Define and track performance levels in site management and monitoring roles and overall delivery to country and regional strategies. Responsible for performance metrics in assigned areas within the regions.
• Oversee and drive quality & compliance and goal related metrics for regions, including FSP management metrics.
• Responsible for regional trend analysis. Identify and analyze regional trends within Site Management & Monitoring, across studies/Tas. Propose and track corrective and preventative actions (CAPAs) as needed with relevant teams. Partner with global teams, including Process Standards Leads, to implement quality improvement initiatives and ensure consistent application of best practices.
• Lead regional communities of practice.
• Provide quality oversight and support to clinical trials across region to ensure inspection readiness. Lead or support audits , inspections and implementation of corrective and preventative actions (CAPAs).
• Partner with DCSOs and global quality teams to proactively identify and mitigate quality risks.
• Deliver training, coaching, and support Site Management & Monitoring teams to enhance quality culture and performance mindset.

• Lead and coach allocated resources within assigned region.
• Overall accountability for the Growth and Development of allocated resources.
• Oversee allocated job functions as described in the relevant job descriptions, and ensure compliance with training requirements.
• Closely liaise with the FSP Managers of allocated resources, as described in standard contracts with the FSP organizations to oversee FSP roles.

• 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

• Extensive knowledge (minimum 10 years) of clinical trial operations, and a thorough understanding of processes associated with site operations and GCP, knowledge of study management and regulatory operations is preferred.

• Demonstrated People management experience.
• Ability to lead and manage diverse teams.
• Strategic thinking and targeted problem solving skills
• Maintains scientific/operational knowledge and expertise to possess credibility to discuss with higher level management and peers.
• Strong interpersonal skills.
• 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 ability to engage with senior stakeholders internally and externally to the organization.
• 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.
• Adherence to Pfizer Values and Actionable Attitudes.

• Reports to Head of Regional Site Operations.
• Member of Regional Site Operations Leadership Team.
• Directly manages regional resources, as appropriate.
• Manages internal relationships with regional leadership, DCSOs, Functional Line Group Leads, Asset DSMs, CTSL Group Leads, Strategic Operations, GCP Quality, OARS, as needed.
• Partners with contracted organizations e.g., FSP monitoring, pCROs and 3rd party vendors as applicable.

• Supports Head of Regional Operations with budget management at regional level

• 8-12 Direct reports

Pfizer