Clinical Site Manager

Astellas Pharma Inc.; United Kingdom; Hybrid; GBP 45,000 - 65,000; Full time

Job summary

A global health partner, Astellas Pharma Inc. is seeking a Clinical Site Manager to oversee trial site operations. The role includes managing site relationships and ensuring compliance with regulations while working in a hybrid model across various locations. Successful candidates will demonstrate strong knowledge of Good Clinical Practices and have experience in therapeutic areas such as Oncology or Gene Therapy.

Benefits

Opportunities for development and growth

Challenging, diverse role in an international setting

Inspiring work environment

Qualifications

• Strong knowledge of GCP, local laws, and regulations.
• Experience in Oncology, Ophthalmology, or Gene Therapy.
• Fluent in English and the local language of the employment country.

Responsibilities

• Act as primary contact for assigned sites across trials.
• Lead site initiation, start-up, monitoring, and close-out activities.
• Manage site relationships and compliance with protocols.

Skills

Knowledge of GCP

Site monitoring

Communication

Problem-solving

Education

BA/BS in life sciences or equivalent

Tools

IT software

Job description

Description

Clinical Site Manager

About Astellas: At Astellas, we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing initially on areas of greatest potential and developing solutions for high-need patient populations, including rare, under-served, life-threatening, or life-limiting diseases. We work directly with patients, healthcare professionals, and regulators to ensure patient and clinical needs guide our development activities at every stage.

Our global vision for Patient Centricity emphasizes understanding the patient experience to develop innovative health solutions. We believe all staff have a role in fostering a patient-centric culture and integrating patient awareness into daily practices. We collaborate with regulatory authorities and payers to improve access to new therapies, providing insights and real-world evidence to inform care decisions. Beyond medicines, we support initiatives to improve awareness, education, access, and standards of care.

This role is part of the Clinical Operations, Development team, based in UK, Poland, Italy, Germany, or Australia. Remote work options are encouraged. We offer a hybrid working model to promote work/life balance, with flexibility for certain locations in accordance with Astellas’ Responsible Flexibility Guidelines.

The Opportunity: As a Clinical Site Manager (CSM), you will serve as the primary contact between the Sponsor and investigational sites. You will oversee trial site readiness, compliance with protocols, SOPs, GCP, and regulations from start-up to closure. You will manage site relationships through communication and support, collaborating with the Clinical Trial Lead, Manager, Specialist, and Study Start-Up Specialist to ensure effective site management and trial activities.

Key Responsibilities:

1. Act as the primary local contact for assigned sites across early and late-phase trials.
2. Lead site initiation, start-up, monitoring (including remote), management, and close-out activities in line with SOPs, Work Instructions, and policies.
3. Implement risk-based monitoring approaches and work with sites to resolve issues promptly.
4. Ensure source documentation and site compliance with ALCOA-CCEA, study protocols, ICH-GCP, and local regulations.
5. Manage up to 10 sites across 2-4 protocols, within budget, and in accordance with T&E guidelines.

Essential Knowledge & Experience:

• Strong knowledge of GCP, local laws, regulations, and protocol-specific procedures.
• Experience in Oncology, Ophthalmology, or Gene Therapy.
• Proficiency with IT software and company systems.
• Extensive site monitoring and management experience.
• Fluent in English and the local language of the employment country.

Education: BA/BS in life sciences or equivalent.

Preferred Experience:

• Cross-functional and matrix team collaboration.
• Mentoring junior monitors and site managers.
• Involvement in early development studies.

Additional Information:

• Permanent, full-time position.
• Based in UK, Poland, Italy, Germany, or Australia with hybrid working.
• Requires at least 1 day per quarter in the local office; flexibility may be needed.

What We Offer:

• Challenging, diverse role in an international setting.
• Opportunities for development and growth.
• Inspiring work environment.

We are an equal opportunity employer, considering all qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, or other protected characteristics.