Country Study Operations Manager I / Gerente de Estudos Clínicos - BRA - São Paulo - CENU

Why Patients Need You 

Pfizer Worldwide Medical and Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to close gaps in data, our mission is simple. Empower healthcare decisions regarding the safe and appropriate use of medicines for patients. 

What You Will Achieve 

You will be part of Pfizer's medical team and manage the clinical studies. Your project management skills will be leveraged for planning, directing, creating and communicating timelines. You will ensure that the clinical studies are within time, budget and scope. 

As a Manager, you provide guidance to operational teams for managing projects. Your planning skills will help in preparing forecasts for resource requirements, and providing areas of improvement for products, processes or services. Through your comprehensive knowledge of principles, concepts and theories of the discipline, you will also work towards advancing new concepts and methodologies. You will be able to take a leadership role to facilitate agreements between different teams. 

It is your problem solving ability and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe. 

How You Will Achieve It 

• Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the division. 

• Oversee the overall execution of clinical studies and be accountable for the development of realistic detailed study startup and monitoring plans. 

• Oversee and support study start up activities at the country level, including review of key documents and providing support to address regulatory and/or ethics committee questions. Forecast and manage the Clinical Trial Budget. 

• Manage full studies for Operational Study Management or manage a unique part of a larger study. 

• Serve as primary point of contact for study decisions related to the protocol, data collection and volunteer activities. 

• Approve and oversee drug supply management and manage flow of drug supply to the sites. 

• Partner with key team members to manage the program to achieve key milestones within time, cost and quality parameters. 

• Work with functional lines and directly with Contract Research Organization (CRO) line functions to resolve or triage site level issues. 

• Share and escalate plan deviations to Clinical Project Manager and study team. 

• Help to address Significant Quality Events or other quality issues at patient and/or site level. 

• Lead the data integrity and data quality activities for assigned protocols. 

• Provide regional and cross-regional insights on study-site performance and trends to / from the study team. 

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Qualifications 

Must-Have 

• Bachelor's Degree 

• 5+ years’ experience 

• Demonstrated project management / leadership experience 

• ​Experience working in the research and development of pharmaceutical industry 

• Experience conducting, managing or participating in regulatory inspection processes 

• Knowledge of project management discipline and its application to vaccine development 

• Country level cultural awareness and strong interpersonal skills 

• Excellent communication skills, both written and verbal in English 

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Nice-to-Have 

• Master's degree 

• Experience in early drug development 

• Knowledge of the project management discipline and its application to vaccine/drug development 

 
Last date to apply for job: July 12th, 2024

EEO (Equal Employment Opportunity) & 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, or disability.