Senior Manager Local Study Operations

Career Category

Clinical

Job Description

If you feel like youre part of something bigger its because you are. At Amgen our shared missionto serve patientsdrives all that we do. It is key to becoming one of the worlds leading biotechnology companies. We are global collaborators who achieve togetherresearching manufacturing and delivering ever-better products that reach over 10 million patients worldwide. Its time for a career you can be proud of. Join us as:

SENIOR MANAGER LOCAL STUDY OPERATIONS

At Amgen Breda medicines are labelled assembledstoredand eventually shipped to various countries worldwide. Every day more than 1000 people with42different nationalities are working on supply chain processes manufacturing marketing and sales of our medicines and clinical research into new medicines.

LIVE

What you will do

In this vital role you will lead and develop a team of Local Study Operations Managers (LSOMs) ensuring the successful delivery of the countrys clinical trial portfolio from feasibility through study close-out.

You will drive operational excellence by overseeing study execution portfolio performance resource planning and quality while fostering collaboration across global and local stakeholders to support Amgens clinical development strategy.

• Lead coach and develop LSOMs building a high-performing team and strengthening capabilities to deliver increasingly complex clinical trials.

• Oversee the delivery of the country study portfolio ensuring studies are executed on time within scope and budget and in line with quality and regulatory requirements.

• Monitor portfolio performance identify risks and quality trends and lead issue escalation mitigation and resolution.

• Manage LSOM and supplier performance ensuring consistent high-quality study execution and achievement of portfolio objectives.

• Drive resource planning and workload allocation across FTE and FSP teams to optimize delivery and align with global priorities.

• Partner with the Country-Hub Head and cross-functional stakeholders to align study strategy support study placement decisions and ensure successful portfolio execution.

• Foster operational excellence through continuous improvement knowledge sharing adoption of best practices and digital innovation.

WIN

What we expect of you

We are all different yet we all use our unique contributions to serve patients. What we seek in you as an experienced professional are these qualifications and skills:

• Degree educated with significant clinical operations experience.

• Around 7 years of experience leading people teams projects or programs within a clinical research environment.

• Proven experience delivering clinical trials within a biotech pharmaceutical or CRO setting.

• Experience managing clinical operations across the Netherlands including strong understanding of local regulatory requirements around global clinical trials.

• Experience overseeing clinical research suppliers (e.g. CROs central labs imaging vendors).

• Strong understanding of global clinical trial operations and local regulatory requirements.

• Ability to manage resources budgets timelines and performance metrics.

• Excellent stakeholder management communication and cross-functional collaboration skills.

• Continuous improvement mindset with the ability to drive operational excellence and implement best practices.

• Fluency in English and in Dutch.

• Monthly presence in the Breda office.

THRIVE

What you can expect of us

As we work to develop treatments that take care of others so we work to care for our teammates professional and personal growth and well-being. Therefore Amgen isregularly recognized as a Best PlaceToWork .

• Vastopportunities to learn and move up and across our global organization.

• Diverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and act.

• Generous Total Rewards Plancomprisingcompetitivesalary bonus structure fixed 13th month holidayallowanceanda collectivehealth insurance.

• Focus on vitality with an on-site gym vitalityprogramand a restaurant with healthy food.

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Required Experience:

Senior Manager

Employment Type : Full-Time
Experience: years
Vacancy: 1