Clinical Site Manager II

About Astellas : At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others. Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners. 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. Our ethos is underpinned by the Astellas Way, comprising five core values : patient focus; ownership; results; openness and integrity. We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.

The Opportunity : A Clinical Site Manager II (CSM II) serves as the primary contact point between the Sponsor and the Investigational Site. A CSM is assigned to trial sites to ensure inspection readiness through compliance with the clinical trial protocol, company Standard Operating Procedures (SOP), Good Clinical Practice (GCP), and applicable regulations and guidelines from study start-up through to site closure. The Site Manager will manage the site / sponsor relationship as it relates to clinical trial delivery through consistent communication and support. The Site Manager will partner with Clinical Trial Lead (CTL), Clinical Trial Manager (CTM), Clinical Trial Specialist (CTS), and Study Start-Up Specialist (SSS) to ensure overall site management while performing trial-related activities for assigned protocols.

Hybrid Working : At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver.

Key Activities for this role :

• Acts as primary local company contact for assigned sites for specific trials. Trials may include both early and late phase clinical trials.
• Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports / dashboards) and site / study close-out according to SOPs, Work Instructions (WIs) and policies. Responsible for the implementation of risk-based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
• Ensure site compliance with study protocol, ICH-GCP, and local / country regulations.
• Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA.
• Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
• May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within Astellas T & E guidelines.

Essential Knowledge & Experience :

• Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
• Solid experience in Oncology, Ophthalmology, and / or Gene Therapy.
• Strong IT skills in appropriate software and company systems.
• Extensive site monitoring and / or site management experience.
• Good command of English and Spanish.

Preferred Knowledge & Experience :

• Worked cross-functionally and within matrix teams.
• Played a key role in executing Lead CSM responsibilities.
• Mentored junior site monitors and site managers.
• Involved in early development studies.

Education / Qualifications :

• BA / BS degree in life science or equivalent.

Additional Information :

• This is a permanent, full-time position.
• Location : Madrid, Spain.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per week in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

What We Offer :

• A challenging and diversified job in an international setting.
• Opportunity and support for continuous development.

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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