Country Study Operations Manager

at  Pfizer

Do you want to be part of an international, innovative, world-class pharmaceutical company? Of an organization committed to putting patients first? Pfizer has always evolved with the changing needs of the people who rely on us to create a healthier world. Guided by our four values: Courage, Joy, Equity and Excellence, our breakthrough culture lends itself to our dedication to transforming millions of lives.
Country Study Operations Manager
Location: Netherlands - Capelle Ad Ijssel
About the role
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.
It is your problem solving ability and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

Main responsibilities

• Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the division.
• 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.
• Approve and oversee drug supply management and manage flow of drug supply to the sites.
• 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.

  About you

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 and Dutch

Nice-to-Have

• Master’s degree
• Experience in early drug development
• Knowledge of the project management discipline and its application to vaccine/drug development

What do we offer?
Innovative company Pfizer has a pipeline full of innovative medicines for a variety of conditions. As a Pfizer colleague, you’ll have the opportunity to maximize the impact of medicines for patients in a variety of ways. In short, you make a real difference.
Development opportunities We are always looking for top talent. We believe you will never stop learning and there will always be a new opportunity for your development. That is why we have broad opportunities in the Belux organization. There are regular opportunities for training or to gain experience in a different field or even advancement to an international position.
A culture where you can be yourself We are a large, international organization with people from all over the world. At Pfizer everyone should be able to be themselves, that’s what we strive for and live by.
Work/life balance At Pfizer, we know that if you really want to make an impact on people’s lives, it’s important that your people are at their best. That’s why we offer our colleagues good working conditions, such as an appropriate salary and opportunities to work from home. Working a lot of overtime is not the norm for us. We also believe that work and having fun should go hand in hand. That’s why, for example, you can participate in all kinds of activities outside of work.
Are you interested?
Do you know enough and have you decided to respond? We are curious about you and invite you to submit your application via the apply button below. You don’t have to worry about a deadline to respond. We keep looking until we have found the right candidate for this position.
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
We kindly ask you to provide your application documents in English!

• Provide guidance, lead/co-lead projects, manage own time to meet objectives and plan resource requirements for projects across the division.
• 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.
• Approve and oversee drug supply management and manage flow of drug supply to the sites.
• 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