Title:  Regional Trial Specialist

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients? 

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deply committed to making a tangible impact.

Astellas’ Global Capability Centres – Overview

Astellas’ Global Capability Centres (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 behaviours, and are critical enablers of the company’s strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.

Working Environment and Location

• This is a permanent, full-time position.
• The position is based in Warsaw, Poland.
• 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 needs. Candidates must be located within a commutable distance of the office.
• At Astellas we recognize the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimize the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

Purpose and Scope

• This position will assist the Global Study Study-Up, Site Management and Monitoring team in the day-to-day operations, set-up, execution and close-out of assigned drug trials, which may include:  pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
• This position is accountable to the Global Study Start-Up, Site Management and Monitoring team for the support of critical activities required for trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables.
• Reports to Head, Global Site Management and Late Phase Monitoring.

Role and Responsibilities

• Support the day-to-day operations of study start-up activities for assigned trials ensuring all site related start up activities are completed in alignment with established project team objectives, milestones and deliverables, and in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Responsible for ensuring maintenance of accurate and up-to-date applicable trial information within relevant tracking systems and providing regular updates as requested to teams and other defined stakeholders.
• Participate in the development of plans and system set-up including input and implementation of appropriate systems, standards, and processes to ensure quality.
• Support site feasibility assessment and maintenance of associated data for trial conduct.  
• Support or lead TMF set-up and maintenance to ensure quality and completeness.
• Support departmental meetings and manage associated documentation as requested.
• Support the coordination of data cleaning and review activities, as applicable to study start-up, site management, and monitoring activities.  Participate in set-up and coordination of investigator and site monitor training, as appropriate.

Continue:Role and Responsibilities

• Participate in the coordination of patient-focused strategies for assigned trials, as appropriate.
• Responsible for complying with regulations, GCP, SOPs and established standards during trial set-up, conduct and close-out.

Essential Qualifications

• Must have BA/BS degree or Associates degree with experience in the health care field or equivalent
• Must have excellent interpersonal, written, verbal, presentation administrative and computer skills. Fluent in English (oral and written)
• General knowledge of drug development and ICH/GCP guidelines
• Fluent in English
• Minimal (0-5%) travel required

Preferred Qualifications

•  Advanced Degree

Benefits

Careers | Astellas

Why Astellas

• Global collaboration: Become part of a connected global business of like-minded life science leaders, all dedicated to improving patients' lives worldwide.
• Real-world patient impact: Contribute to transformative therapies that reach patients around the world, knowing your work makes a difference every day.
• Relentless Innovation: Join a company at the forefront of scientific breakthroughs, where you'll have the opportunity to shape the future of healthcare.
• A Culture of Growth: Chart your own course within a supportive environment that values your contributions, champions your development, and empowers you to pursue your passions.

Our Organisational Values and Behaviours

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We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.

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