Clinical Site Manager (CSM)

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.

This role forms a part of the Clinical Operations, Development team. This position is based in UK, Poland, Italy, Germany and Australia. Candidates interested in remote work are encouraged to apply.

The Opportunity:

As a Clinical Site Manager (CSM), you will serve as the primary contact point between the Sponsor and the Investigational Site. You will be 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 to site closure. You will manage the site/sponsor relationship as it relates to clinical trial delivery through consistent communication and support.

You will partner with the 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.

Responsibilities:

• Acting as a primary local company contact for assigned sites for specific trials. Trials may include both early and late-phase clinical trials.
• 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.
• Being responsible for implementing risk-based monitoring approaches at the site level and working with the site to ensure timely resolution of issues found during monitoring visits.
• Ensuring source and other site documentation is adequate and in compliance with ALCOA-CCEA. Ensuring site compliance with the study protocol, ICH-GCP, and local/country regulations.
• Taking accountability for up to 10 sites across 2-4 protocols, dependent on the complexity of protocols and site activity. Being 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.
• Proficient in English and the primary language of the country of employment.

Education/Qualifications:

• BA/BS degree in life science or equivalent.

Preferred Experience:

• Worked cross-functionally and within matrix teams.
• Mentored junior site monitors and site managers.
• Involved in early development studies.

Additional Information:

• This is a permanent full-time position.
• This position can be based in the UK, Poland, Italy, Germany, and Australia
• This position is 100% home/remote.

What We Offer:

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

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.