ROLE
1. The Director of Site Management and Monitoring (DSMM), in partnership with the Director of Clinical Site Operations (DCSO), is accountable for ensuring appropriate site management and monitoring resources (e.g., Site Care Partner (SCP), Clinical Research Associate (CRA), Site Monitor) 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, as well as providing line management, overseeing the job function of the roles.
2. The DSMM supports the DCSO, who is accountable to ensure overall site operations and site management and monitoring activities within designated countries/clusters/regions and supervises requirements for sites to ensure participant safety and quality of study execution in accordance with applicable prevailing laws, Good Clinical Practice, and Pfizer standards.
3. The DSMM 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 designated countries/clusters/regions, when applicable. The role also executes investigator site/recruitment strategies and site-level end to end study start-up, management and monitoring activities.
4. The DSMM will lead, contribute to, and implement strategic initiatives as a representative of GSSO Leadership. They will also lead initiatives that shape the clinical development environment within designated countries/clusters/regions 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/site organization 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).
5. The DSMM may be aligned with assets within Therapeutic Areas to serve as a strategic point of contact for items such as planning, quality events, inspections. The DSMM may be aligned to a centralized service (e.g., informed consent processing) to serve as a strategic point of contact / lead for items such as planning and delivery.
6. The DSMM 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.
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 assessperformance.
· Demonstrate leadership in the resolution of site/country/cluster/regional issues to maintain site startup,
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.
QUALIFICATIONS / SKILLS
Indicate qualifications and skills that are necessary for performance of responsibilities including: education, relevant experience,
licenses, certifications and other job-related technical and managerial 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:
Ø BS/BSc/MS/MSc or equivalent and extensive clinical research experience
Ø 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.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Égalité des chances & Emploi
Nous croyons que des équipes diversifiées et inclusives sont essentielles à la réussite d'une entreprise. En tant qu'employeur, Pfizer s'engage à valoriser la diversité et l’inclusion sous toutes ses formes. Cette diversité se reflète également à travers les patients et les communautés que nous servons. Ensemble, continuons à bâtir une culture qui encourage, soutient et responsabilise nos employés.
Handicap & Inclusion
Notre mission est de libérer le potentiel de nos collaborateurs et nous sommes fiers d'être un employeur inclusif pour les personnes handicapées, garantissant ainsi l'égalité des chances en matière d'emploi pour tous les candidats. Nous vous encourageons à donner le meilleur de vous-même en sachant que nous apporterons tous les ajustements raisonnables pour soutenir votre candidature et votre carrière future. Votre expérience avec Pfizer commence ici !
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