About Astellas:
At Astellas we can offer an inspiring place to work and a chance to make your mark in doing good for others.
Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society.
Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.
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.
Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.
We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership.
Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.
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.