Clinical Trial Associate

Clinical Trial Associate

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 care-givers, 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:

As the Clinical Trial Associate, 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).

You will be accountable to the clinical trial team for the support of the trial execution and will work collaboratively with cross-functional team members and vendors to ensure the proper set-up of trial processes and plans to execute the protocol with operational excellence and in accordance with SOPs and standards to ensure the quality of trial deliverables.

Key Responsibilities:

• Supporting the day-to-day operations of assigned trials and responsibilities and ensuring completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements.
• Maintaining accurate and up-to-date trial information within relevant tracking systems and providing regular updates as requested to the trial team and other defined stakeholders.
• Participating in the development of core trial documents and trial-level plans, as requested and/or leading on trial-related systems set-up including implementation and maintenance of appropriate systems, standards and processes to ensure quality across investigative sites, vendors and data.
• Contributing to the feasibility assessment and selection of countries and sites for trial conduct.
• Ensuring CRO and vendor set-up and management during clinical trial execution, as requested by the clinical trial lead and/or clinical team.

Essential Knowledge & Experience:

• Clinical trial experience ideally within a sponsor setting.
• Strong knowledge of ICH/GCP guidelines and regulatory requirements as well as knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
• Participated in or facilitated site engagement and communications with investigators and/or staff to support trial milestones and deliverables.
• Ensured quality and completeness of TMF for assigned clinical trials.
• Participated in CRO and vendor set-up and management during clinical trial execution, as requested by the clinical trial lead and/or clinical team.
• Supported in data cleaning and data review activities as requested.

Preferred Experience:

• Project management skills and trial leadership ability.

Education/Qualifications:

• Bachelor’s Degree or equivalent.

Additional Information:

• This is a permanent, full-time position.
• This position is based in the UK and US.
• This position is 100% home/remote based.

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.