Clinical Site Manager

Description

Clinical Site Manager

About Astellas: At Astellas, we offer an inspiring workplace and the chance to make a positive impact. Our expertise, science, and technology define us as a pharma company. Our open and progressive culture fosters doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients motivates us. We work locally, leveraging global insights and external partnerships. Our global vision emphasizes Patient Centricity, supporting innovative health solutions through understanding the patient experience. Patient Centricity guides our actions, with all staff playing a role in fostering a patient-centric culture. Our values include patient focus, ownership, results, openness, and integrity. We promote an inclusive environment that encourages collaboration and ownership. We aim to bring together talented individuals equipped with top-tier tools and resources, fostering agility and entrepreneurial spirit.

Role Overview: The Clinical Site Manager (CSM) acts as the primary contact between the Sponsor and Investigational Sites. You will oversee assigned trial sites to ensure readiness and compliance with protocols, SOPs, GCP, and regulations from start-up to closure. You will manage relationships with sites and sponsors, ensuring effective communication and support. Collaboration with the Clinical Trial Lead, Clinical Trial Manager, Clinical Trial Specialist, and Study Start-Up Specialist is essential for comprehensive site management and trial activities.

Responsibilities:

1. Serve as the main local contact for assigned sites for specific trials, including early and late-phase trials.
2. Lead site initiation, start-up, monitoring (including remote), management, and close-out activities in accordance with SOPs, WIs, and policies.
3. Implement risk-based monitoring at the site level and work with sites to resolve issues promptly.
4. Ensure source documentation and other site records comply with ALCOA-CCEA standards and that sites adhere to protocols, ICH-GCP, and local regulations.
5. Manage up to 10 sites across 2-4 protocols, managing travel budgets within company guidelines.

Essential Knowledge & Experience:

• Strong knowledge of GCP, regulations, protocols, and monitoring guidelines.
• 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 employment.

Preferred Experience:

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

Education/Qualifications:

• BA/BS in life sciences or equivalent.

Additional Information:

• Permanent, full-time position.
• Locations include UK, Poland, Italy, Germany, and Australia.
• Remote work available.

What We Offer:

• Challenging, diverse roles in an international environment.
• Support for continuous development.
• Inspiring work climate.

We are committed to equal opportunity employment, considering all qualified applicants without discrimination based on race, color, religion, sex, national origin, disability, veteran status, or other protected characteristics.