GSSO Process & Standards Lead
GSSO Process & Standards Lead
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$ 242000 - 403400
1 Vacancy
Job Description
POSITION SUMMARY
The Process and Standards Group Lead is a strategic role critical to the development of Global Site and Study Operations (GSSO) and associated processes and standards. You will influence clinical trial development start-up and execution across study management site management and monitoring. You will work across GSSO processes and lead a team of Subject Matter Experts (SME) including Global Business Process Owners (BPO) and Business Process Experts (BPE) where applicable.
KEY RESPONSIBILITIES
Lead a team to deliver on study management site management and monitoring processes.
Partner with stakeholders and functional lines to ensure understanding of processes change recommendations and gain consensus on business requirements.
Identify opportunities for process improvements in response to compliance changes regulatory inspections business strategy performance signals feedback from stakeholders and industry benchmarks; implement required changes.
Assess and communicate process performance across GSSO.
Serve as process point person for inspections audits and quality events including compliance readiness support and remediation.
Act as point of accountability for all corrective and preventative actions arising from inspections audits and quality events.
Resolve escalated process issues and questions.
Develop and maintain consistent onboarding and ongoing training materials and processes for all related roles.
Champion the implementation and use of harmonized consistent processes and excellence across GSSO deliverables.
Collaborate with leadership to lead new initiatives and ideas for more efficient ways to work and build and maintain talent within GSSO.
Serve as point of contact for study and site management standards continuous improvement issue escalation/resolution inspection readiness/quality assurance performance feedback and review and management of metrics.
Oversee monitoring and ensure compliance at investigator sites following up at an enterprise level when trends in monitoring practices are identified.
MINIMUM QUALIFICATIONS
BA/BS with 12 years of clinical development experience including experience with site and or study management OR
MS with 10 years of clinical development experience including experience with site and or study management OR
PhD with 7 years of clinical development experience including experience with site and or study management
Extensive global clinical trial/study and site management experience.
Working knowledge of GCPs monitoring clinical and regulatory operations
Experience leading cross-functional initiatives integrations and process improvement work streams.
Experience leading a team and people management experience
Experience working in a multidisciplinary matrix team environment.
Strong leadership influencing negotiation and management skills.
Experience proactively identifying and mitigating risks around study execution site management and monitoring.
Excellent communication skills both written and verbal.
Candidate demonstrates a breadth of diverse leadership experiences and capabilities including: the ability to influence and collaborate with peers develop and coach others oversee and guide the work of other colleagues to achieve meaningful outcomes and create business impact.
NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS
Up to 20% travel
Work Location Assignment:Remote
Relocation assistance may be available based on business needs and/or eligibility.
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race color religion sex sexual orientation age gender identity or gender expression national origin disability or veteran status. Pfizer also complies with all applicable national state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States.
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Employment Type
Full-Time
