Clinical Site Manager Ii
hace 1 mes
Clinical Site Manager II
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing 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.
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.
Key Activities for this role:
Acts as primary local company contact for assigned sites for specific trials.
Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring, site management, and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
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.
May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity.
Essential Knowledge & Experience:
Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures.
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.
Educations/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.
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.
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