Study Start-Up Specialist

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: As a Study Start-Up Specialist, you will be a local expert in Study Start-Up (SSU) activities and strategy, including using various clinical systems (e.g., CTMS) to enable consistent and compliant forecasting and data collection. You will work within Clinical Operations both early and late and with partnering functions (e.g., IT, IS) by adhering to standard operational terminology and data conventions used for clinical systems. This site-facing role will support the global SSU team by efficiently managing and tracking assigned site activations. You will also provide administrative support related to various clinical systems/technology utilized by Clinical Operations. This position has no direct reports.

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:

• Supporting the day-to-day operations of assigned activities within SSU 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.
• Identifying and escalating issues that arise related to supporting SSU deliverables and effectively executing against assigned activities within SSU.
• Ensuring oversight of site-level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release, and other site activation requirements.
• Generating and providing accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools.
• Leading the preparation of study-level essential document templates, aiding in the preparation of content for Regulatory submissions, handling ICF negotiations and facilitating any required escalations, and being involved in the preparation and submission of IMP Release Packages.

Extensive clinical trial experience and clinical trial conduct. Good understanding of local SSU processes and requirements. Proficient in English and the primary language of the country of employment. General knowledge of drug development and ICH/GCP guidelines.

Preferred Experience:

• Worked cross-functionally and within matrix teams.
• Involved in early development studies.

Education/Qualifications:

• BA/BS degree in life science or equivalent.

Additional Information:

• This is a permanent, full-time position.
• This position is based in the UK, France, Germany, Italy, Spain and Poland.
• 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.