Clinical Trial Manager

About Astellas

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  .

This position is a permanent, full-time and reports into the Clinical Operations Lead (Early Development) and sits within Clinical Operations Excellence (COE). This position is hybrid and will require you to be onsite 1 day per quarter in Addlestone, United Kingdom office. Moderate (~10%) travel required.

At Astellas we recognise the importance of work/life balance, and we are proud to offer a hybrid working solution allowing time to connect with colleagues at the office with the flexibility to also work from home. We believe this will optimise the most productive work environment for all employees to succeed and deliver. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.

The Clinical Trial Manager is responsible for supporting/leading specific activities for the planning, set-up and execution of assigned drug trials which may include: pre/post-POC interventional drug trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).

This position is accountable to the Clinical Trial Lead and Operations Lead for trial execution and works collaboratively with cross-functional team members and vendors to ensure proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure quality of trial deliverables.

• Manage the day-to-day operations of assigned trials and responsibilities to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Leads or supports cross-functional trial teams, including vendors.
• Ensures accurate and up-to-date trial information within relevant tracking systems and provide regular updates of trial progression to Clinical Operations Lead, Clinical Trial Lead, and other defined stakeholders.
• Proactively identify and resolve issues that arise during trial conduct; manage escalation of trial-related issues.
• Participate in or lead the development of core trial documents, trial plans, site communications and system set-up; participate in preparation and ensure operational excellence of protocol and implementation of appropriate systems, standards, and processes to ensure quality across investigative sites, vendors, and data.

• Participate in or lead preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team.
• Participate in or lead feasibility assessment and selection of countries and sites for trial conduct.
• Participate in or facilitates site engagement and communications with investigators and/or staff to support trial milestones and deliverables.
• Oversee the clinical aspects of timely data cleaning, data analysis and the availability of top line results; participate in data reviews including overseeing vendor data reconciliations.
• Participate in or lead set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members.
• Provide oversight and direction to trial team members for trial deliverables.
• Manage clinical trial budget with associated vendor contracts, including tracking and data in associated systems.
• Participate in or lead set-up of the TMF and ensure quality and completeness of TMF for assigned clinical trials.
• Participates in inspection readiness activities including coordination of clinical trial team deliverables.
• Participate in the evaluation and implementation…