Description

Clinical Site Manager II

About Astellas

At Astellas, experience is coupled energised with a relentless challenger spirit.

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 are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation.

We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers.

We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients.

The Opportunity

As a Clinical Site Manager (CSM II), 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.

You will report to the Site Management Lead II. Your role forms a part of the Clinical Operations, Development team.

Hybrid Working

At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.

Key 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

• Extensive site monitoring and/or site management experience.
• Experienced working in early development studies within Oncology.
• Strong working knowledge of GCP, local laws and regulations, assigned protocols, and associated protocol-specific procedures including monitoring guidelines.
• Strong IT skills in appropriate software and company systems.
• Proficient in speaking and writing English and to be fluent in local language (Spanish).
  
  

Preferred Experience

• Experienced in executing Lead CSM role.
• Worked cross-functionally and within matrix teams.
• Mentored junior site monitors and site managers.
  
  

Education

• BA/BS degree life science or equivalent.
  
  

Additional Information

• This is a permanent, full-time position.
• This position is based in Madrid, Spain.
• Willingness to travel up to 40% with overnight stay away from home.
• This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.
  
  

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.