Regional Clinical Site Lead
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About the position
For our location in Capelle aan den Ijssel, we are looking for a Clinical Site Lead, who is the main Pfizer point of contact for investigative sites as well as accountable for safeguarding the quality and patient safety at the investigator site. As the Clinical Site Lead you report to the Directors of the Clinical Site Management. You works in close relationship to the Study Management Group Lead and the Targeted Investigator Network Strategy Implementation Lead. You also coordinate with institutions and investigators at the local level and with the CRO in The Netherlands.
The Clinical Site Lead is responsible for site monitoring and oversight and building and retaining relationships from site activation through the lifecycle of studies. As part of the oversight responsibilities, this role will utilize and interpret data from analytic tools, in conjunction with country and regional intelligence to proactively identify risks to quality and compliance and to develop and implement mitigation plans to address these risks.
The Clinical Site Lead is the “face of Pfizer” and therefore accountable for ensuring that sites receive necessary support and engagement, issues are resolved, and Pfizer’s reputation is that of “Partner of Choice”.
The main responsibilities are:
- Usher investigator sites through site activation and study activities from study start up to close out
- Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback
- Provide country/regional level input to country outreach surveys including protocol feasibility, country SOC and medical practices
- Provide country/regional level input to country strategy/planning and site recommendation through intimate understanding of country, sites, processes and practices, and associated site performance metrics
- Support local CRO representatives develop positive Investigator relationships throughout the life of the study and escalate any training or compliance concerns with Site Oversight Lead and Study Management
- Excellent site and monitoring quality, regulatory and GCP compliance
- Drive inspection readiness and provide support for site audits/inspections as needed, following through audit/inspection finding to resolution
- Maintain a thorough knowledge and understanding of assigned protocols, including associated risks and mitigations, as it relates to site and monitoring quality
- Attend Investigator meeting/protocol training to ensure clear understanding of the protocol requirements
- Support local Investigator relationship management with the Site Operations Relationship Lead
This position requires regularly travelling within the country and region.
Education: A Masters degree with a scientific or technical degree in the healthcare area is preferred.
Language skills: Fluent English written and spoken required, spoken Dutch as an advantage.
- 5+ years of clinical research experience and/or quality management experience
- Solid knowledge of clinical development processes with strong emphasis on monitoring of clinical trial methodology
- Demonstrated ability to oversee a 3rd party and/or demonstrated ability in Quality Assurance
- Project management experience, ability to lead, troubleshoot and influence for delivery
- Experience implementing centrally designed and developed initiatives on a local basis
- Communicate effectively and appropriately build networks with internal & external stakeholders
- Encourage changing technologies and processes in developing strategies and future directions
- Evaluate, interpret and present complex issues and data to support assessment and mitigation of site risk
- Innovative and independent approach to build and maintain a competitive advantage
For this position we need you to challenge people to surpass themselves in reaching their objectives using innovative solutions, to motivate through example, commitment, loyalty and enthusiasm.
Of course we offer excellent working conditions with flexible working hours. And in addition to the efforts we expect from you, there is also plenty of time and attention for relaxation. For example, during the year we organize various sports activities, drinks and voluntary work during working hours / Pfizer4All. You can get in touch with all your other colleagues in a relaxed way.
Sounds like you and have you decided to respond? We are interested in you and invite you to submit your application via the application button below.
Selected candidates who would be based in The Netherlands must have the authorization to live and work in The Netherlands
We do not respond to requests from recruitment agencies
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.