Senior Specialist, Clinical Operations Process Optimization
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.
We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
We are looking for a Senior Specialist in Clinical Operations Process Optimisation. In this role, you will help improve and coordinate the processes and systems used in clinical trials. You will work with teams that manage clinical studies to make sure they follow the best methods and tools.
Your main goal will be to improve how clinical trials are planned and run. You will help design and manage tools, standards, and communication strategies that support clinical operations. You will also support change management and help teams understand and use new processes.
This role involves working with many different teams across the company and with external partners. You will help make sure clinical operations are efficient, cost-effective, and completed on time.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
Key Responsibilities:
- Develop and manage standard processes and tools for clinical operations teams.
- Work with internal teams and external partners to ensure consistent use of these processes.
- Act as a subject matter expert to support clinical study teams using different models (in-house, outsourced, or mixed).
- Provide training, tools, and guidance to help teams manage clinical trials effectively.
Essential Knowledge & Experience:
- Experience working in the pharmaceutical industry or with a Clinical Research Organization (CRO).
- Strong change management experience.
- Experience working with both internal teams and external partners.
- A strong interest in improving processes and working in a global environment.
Education:
- University degree or equivalent.
Additional Information:
This is a permanent role based in our Global Capability Centre in Warsaw, Poland and hybrid working with the expectation for some office presence. Flexibility may be required in line with business need. Candidates must be located within a commutable distance of the office.
Astellas’ Global Capability Centres – Overview:
Astellas’ Global Capability Centre’s (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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