Clinical Trial Manager - United Kingdom
About Astellas:
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focusing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions.
We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage.
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 work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their caregivers, to ensure the medicines we develop continue to provide meaningful outcomes.
Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
The Opportunity:
An exciting opportunity to contribute to pivotal trial launches and new programs, where we welcome fresh ideas and innovative ways of working — giving you the chance to share your expertise and make a meaningful impact on our processes.
In this role, you will be responsible to support or lead specific activities for the planning, set-up and execution of assigned drug trials which may include: pre/post-POC interventional drug trials, Clinical Pharmacology normal healthy volunteer clinical trials, pre-approval access and post-marketing regulatory commitment trials (interventional and non-interventional).
Be 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. The position has no direct reports but may provide oversight and direction to trial team members for trial deliverables.
Hybrid Working:
At Astellas you are empowered and supported with hybrid working options where you can work where you feel most comfortable and productive.
Key Activities For This Role:
- 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.
- Lead or support 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 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 and review of statistical analysis plans.
- 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 and associated vendor contracts, including tracking and data in associated systems.
- Ensure quality and completeness of TMF for assigned clinical trials.
- Participate in inspection readiness activities including coordination of clinical trial team deliverables.
- Participate in the evaluation and implementation of patient-focused strategies for assigned trials, as applicable.
- Responsible for the management of budgets, timelines and resources for assigned clinical trial responsibilities.
Essential Knowledge & Experience:
- Must have strong knowledge of ICH/GCP guidelines and regulatory requirements.
- Must have knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
- Requires project management skills and trial leadership ability.
- Must have excellent interpersonal, written and verbal communication skills, administrative skills and computer ability.
- Study management experience is key.
- Fluent in English.
- Moderate (~25%) travel required.
Preferred Experience:
- Ability to thrive in a collaborative, cross-functional environment — working effectively with a range of teams, roles, and personalities.
- Comfortable to also work independently, showing initiative and resourcefulness to problem-solve and exchange ideas with colleagues.
- Flexibility and the ability to manage multiple priorities
Education:
- A BA/BS degree with proven clinical trial experience, OR an advanced degree (MS/PhD/PharmD) with relevant hands-on clinical trial experience.
Additional Information:
- This is a permanent, full-time position, based in the United Kingdom.
- This position follows our hybrid working model. Role requires a blend of home and minimum once a quarter in office. Flexibility may be required in line with business need.
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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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