Senior Director Clinical Site Operations
il y a 1 mois
ROLE
- Reporting to the Head of Site & Country Operations, the Pfizer Oncology Division (POD) Senior Director of Clinical Site Operations (Senior DCSO) is a dynamic leader supporting the Head of Site & Country Operations to deliver their strategic vision and representing POD operations at the country or cluster level.
- Represents POD at the country or cluster level playing a critical role establishing and cultivating relationships with KOLs, strategic sites/ networks, HAs/governments and industry clinical research associations to become the Face of Pfizer and positioning Pfizer as a partner of choice within their country/cluster.
- Supports and cultivate a collaborative partnership with Medical Affairs, creating a framework for an end-to-end continuum linking investigator relationships to future prescribers within the country.
- The Senior DCSO influences leadership decisions that impact business, will build and leverages constructive internal relationships within POD and PRD, to drive strategic initiative/success.
- Demonstrated knowledge and understanding of the local marketplace, and industry trends, providing insights and enabling teams to successfully position and deliver oncology clinical trials
- Leads the GSSO organization within their country/cluster to deliver the Pfizer oncology portfolio, driving a meaningful increase in patient recruitment whilst meeting and exceeding speed and quality deliverables and best in class cycle times to bring medicines to patients faster.
- The Senior DCSO may sponsor, chair, or lead operational strategic initiatives, to accomplish business objectives that are multifaceted and unique in complexity. Also encompassing and empowering an extensive team / line management, mentoring and coaching duties.
JOB RESPONSIBILITIES
- The Senior DCSO is accountable for ensuring appropriate Site Care Partner (SCP), and Site Monitor resources are in place to deliver on, country and site-level end to end activities in-line with study milestones in the designated countries/clusters. This role provides line management and oversees the Site Care Partner and Site Monitor ensuring compliance with training requirements. The Senior DCSO is accountable to ensure overall monitoring, operational site partnership, management and oversight activities within a designated country/cluster 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.
- Overall accountability for the Growth and Development of the Site Operations organization (Managers and
- Individual Contributors) and to ensure compliance with training requirements.
- Partner with the FSP Manager of Site Care Partner & Site Monitors as described in standard contracts with the FSP
- organization to oversee FSP SCP and Site Monitor roles. Senior DCSO is accountable to ensure timely resource assignments and will provide feedback on the performance of FSP resources.
- Accountable for country/cluster budget in accordance with financial expectations.
- Demonstrate leadership in the resolution of site/country/cluster issues to ensure project delivery, patient safety, quality and maintain investigator site relationships
- This is a strategic role that coordinates cross functionally with Study Start Up, Operational Analytics and Quantitative Sciences (OARS), Patient Recruitment and Study Management, providing local knowledge and critical input to country and site selection. investigator site relationships
- Collaborate with country regulatory/regional Clinical Trial Regulatory operations (CTRO) to facilitate Clinical Trial Application/IRB/EC approval for allocated studies in their country/cluster.
- The Senior DCSO represents Pfizer Oncology Divisions (POD) as the operational partner for the local country/regional Medical Affairs teams. This role drives the end-to-end connection of country/cluster stakeholders across the portfolio and collaborates with other stakeholders at the global level to ensure country input into the clinical development and country strategy.
- This role is responsible for the communication of the future trial portfolio to appropriate country/cluster stakeholders.
- Responsible for country level input into country selection, pre-feasibility, study design and site
identification and selection and ensure that feedback on country/site decisions is effectively communicated to appropriate stakeholders.
- The Senior DCSO will lead, contribute to, and implement strategic initiatives as a representative of the GSSO Leadership. Leading initiatives that shape the clinical development environment within their country/cluster 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 auth
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Senior Director Clinical Site Operations
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