Clinical Trial Associate

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: In this position, you will assist the Clinical Trial Lead(s) and Clinical Trial Manager(s) in the day-to-day operations, set-up, execution, and close-out 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 team for the support of the 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. This role reports to the Functional Manager, Clinical Operations or Clinical Operations Lead.

Hybrid Working: At Astellas we recognize 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 optimize 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.

Key Activities For This Role:

• Support 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.
• Responsible for maintaining accurate and up-to-date trial information within relevant tracking systems and provide regular updates as requested to trial team and other defined stakeholders.
• Participate in the development of core trial documents and trial level plans, as requested.
• Participate in or lead trial related systems set-up including implementation and maintenance of appropriate systems, standards and processes to ensure quality across investigative sites, vendors and data.
• Participate in feasibility assessment and selection of countries and sites for trial conduct.
• Participate in CRO and vendor set-up and management during clinical trial execution, as requested by clinical trial lead and/or clinical team.
• Participate in or facilitate site engagement and communications with investigators and/or staff to support trial milestones and deliverables.
• Ensure quality and completeness of TMF for assigned clinical trials.
• Participate in trial team meetings and manage associated documentation as requested.
• Participate in data cleaning and data review activities as requested.
• Participate in or lead set-up and implementation of effective investigator and site monitor training.
• Participate in the coordination and implementation of patient-focused strategies for assigned trials, as applicable.
• Responsible for complying with regulations, GCP, SOPs and established standards during trial set-up, conduct and close-out.

Essential Knowledge & Experience:

• Must have systems experience (i.e. TMF, CTMS, EDC, IRT).
• 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.
• Fluent in English.
• Moderate (~25%) travel required.

Education:

• A BA/BS degree with proven clinical trial experience.
• Advanced Degree is a nice to have.

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.