About Astellas is a global life sciences company committed to turning innovative science into value for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.
Study Start-Up / Site Activation Manager
This is a permanent full‑time position based in the UK, reporting to the Head Site Activation, UK and sitting within Clinical Operations Excellence (COE). The role is hybrid and will require being onsite 1 day per quarter at the Bourne office in London, UK. Flexibility is provided to work from home or the office as needed.
Purpose & Scope
As a Study Start‑Up / Site Activation Manager you will be responsible for Study Start‑Up (SSU) activities and strategy, including use of clinical systems such as CTMS to enable consistent and compliant forecasting and data collection. You will represent Clinical Operations on cross‑functional initiatives and systems implementation teams, articulate business‑process requirements for clinical trials, define standard terminology and data conventions, and define user roles, permissions and training requirements. You will work with partnering functions such as IT and IS to support development of robust functional requirements for new or enhanced applications and reports.
Responsibilities
* Manage and lead day‑to‑day operations within Study Start‑Up to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements, coordinating with key stakeholders such as study teams.
* Lead functional and cross‑functional internal teams.
* Provide accurate, up‑to‑date project status and financial information through relevant tracking systems and tools.
* Proactively identify and escalate issues related to support functional deliverables.
* Implement standards for designated functional areas.
* Provide oversight and direction to team members for functional and study‑related deliverables.
* Accountable for functional budgets and resources, managing related components of trial or support function budgets, timelines and resources.
* Oversee all activities associated with Study Start‑Up, from receipt of a potential site list to site activation, including CDA and questionnaire collection, site selection, IRB/EC submissions, IMP release and other site activation requirements.
* Facilitate development of the SSU strategy and manage its execution during the study start‑up period.
* Build relationships with key study team counterparts to support successful site activation strategies and ensure appropriate delegation of tasks during SSU.
* Drive site activation timelines, assist with mitigations and escalations to keep milestones on track.
* Contribute to process and tool development to support the SSU team with day‑to‑day activities.
* Lead preparation of study‑level essential document templates.
* Assist in preparation of content for regulatory submissions and support ICF negotiations and escalations.
* Review and approve IMP release packages.
Required Qualifications
* Knowledge of clinical trial conduct, including multi‑centre, global trials and global site activation requirements.
* Strong knowledge of drug development and ICH/GCP guidelines.
* Good understanding of local SSU processes and requirements.
* Proven project management skills and leadership ability.
* Excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
* BA/BS degree in life science or equivalent.
Preferred Qualifications
* Global experience with site activation activities including submission requirements.
* Experience working cross‑functionally and with external providers.
* Experience with development and implementation of process improvement initiatives.
Benefits
* Global collaboration: Be part of a connected global business of life‑science leaders dedicated to improving patients' lives worldwide.
* Real‑world patient impact: Contribute to transformative therapies that reach patients globally, knowing your work makes a difference every day.
* Relentless innovation: Join a company at the forefront of scientific breakthroughs, shaping the future of healthcare.
* A culture of growth: Chart your own course in a supportive environment that values your contributions, champions your development and empowers you to pursue your passions.
Equal Opportunity Statement
We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
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