The Regional Operations Lead (ROL), in partnership with the Head of Regional Site Operations and the Directors of Clinical Site Operations (DCSOs), is responsible for delivering on regional strategies, and overseeing the appropriate execution and compliance of clinical trial site management and monitoring activities conducted in their assigned geographical area.
The ROL will support the Head of Regional Site Operations who is responsible for implementation of regional-level strategies to optimize program level allocation and enable clinical study delivery in partnership with Asset Leads, Business Units, Country Management and Strategic Partners. They may represent the region in global operational forums including Feasibility Alignment Meetings, Feasibility Kick-off Meetings, GSSO Info Share Sessions and Country Strategy Meetings, and contribute to country allocation decisions.
The ROL will be responsible for, or oversee a team responsible for, driving operational excellence, compliance and continuous improvement in Site Management & Monitoring across assigned regions. This role will leverage data and analytics to drive performance improvements, quality oversight and audit readiness, ensuring clinical trials are conducted in alignment with Good Clinical Practice (GCP), regulatory requirements and Pfizer standards. They will work closely with DCSOs, Regulatory, Strategic Operations Business Process Owners (BPOs), GCP Quality, Medical Affairs and other stakeholders, and contribute to CD&O & enterprise-wide process optimization initiatives. The ROL will participate as required on regional/global initiatives and represent the region/s as needed.
The ROL will support the Head of Regional Site Operations to ensure optimal allocation and utilization of Site Management & Monitoring resources across the region to meet business and project demands. The role involves strategic workforce planning, forecasting, balancing supply and demand, and ensuring appropriate resourcing for current and future projects.
Regional Strategy Implementation and Country Allocation Activities:
- 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.
Resource Management
- 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).
Performance and Quality Oversight
- 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.
Line Management of Site Management and Monitoring roles (as required)
- 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.
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 operations, and a thorough understanding of processes associated with site operations and GCP, knowledge of study management and regulatory operations is preferred.
Skills
- 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.
Organizational Relationships
- 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.
RESOURCES MANAGED
Financial Accountability
- Supports Head of Regional Operations with budget management at regional level
Supervision
- 8-12 Direct reports
The selected candidate can be based anywhere in Europe. This is a remote based position.
Purpose
Breakthroughs that change patients’ lives… At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.
Flexibility
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!
Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Disability Inclusion
Our mission is unleashing the power of all our people and we are proud to be a disability inclusive employer, ensuring equal employment opportunities for all candidates. We encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments to support your application and future career. Your journey with Pfizer starts here!
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