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:
You will be responsible for the execution of assigned tasks within the relevant Clinical Operations support function for both early and late stages.
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 Responsibilities:
- Manage and lead the day-to-day operations within relevant support functions to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. This includes effective communication and coordination with key business stakeholders (e.g., study teams) to support the timely completion of both drug and non-drug program goals and objectives.
- Provide accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools.
- Guide Clinical Operations Compliance-related activities inclusive of a holistic evaluation of CO-related audit findings, execution of CAPA and process-related effectiveness checks, and CO inspection readiness support.
- Site Contracting activities including interacting with Site Budgets and Payments.
- Manage Clinical Operations Vendor oversight/performance activities inclusive of vendor capability evaluation & selection, management of assigned vendors, planning/delivery of vendor governance meetings, analysis of key performance measures, and vendor issue escalation.
- Provide oversight and direction to team members for functional and study-related deliverables.
Essential Knowledge & Experience:
- Solid knowledge of clinical trial conduct, including, multi-center, global trials.
- Strong knowledge of ICH/GCP guidelines and regulatory requirements.
- Proven project management skills and leadership ability.
- Experience in pharmaceutical-related drug development.
- Excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
- Good command in English and in Spanish.
Preferred Knowledge & Experience:
- Involved in the global clinical trial space.
- Worked cross-functionally and with external providers.
- Contributed to the development and implementation of process improvement initiatives.
Education/Qualifications:
- BA/BS degree or equivalent.
Additional Information:
- This is a permanent, full-time position.
- Position is located in Spain.
- 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.
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.