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 Clinical Trial Manager, you will be responsible for providing support or leading 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).
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 the quality of trial deliverables.
This position is based in the UK or US. At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver. Candidates interested in remote work are encouraged to apply.
Key Responsibilities:
- Managing 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.
- Leading or supporting cross-functional trial teams, including vendors.
- Participating in or leading in the set-up and implementation of effective investigator and site monitor training; coordinate operational and therapeutic area training for internal and external trial team members.
- Leading 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.
- Ensuring 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.
Essential Knowledge & Experience:
- Demonstrable knowledge of protocol and clinical drug development processes, clinical trial design, trial planning and management, and monitoring.
- Project management and trial leadership experience.
- Participated in or led the preparation of vendor requirements and project scope and selection of trial vendors; effectively manage interactions and escalations with vendor trial team.
- Demonstrable knowledge of ICH/GCP guidelines and regulatory requirements
- Managed the clinical trial budget with associated vendor contracts, including tracking and data in associated systems.
Preferred Experience:
- Facilitated site engagement and communications with investigators and/or staff to support trial milestones and deliverables.
- Demonstrated vendor management experience.
- Phase I experience in Rare Disease, Gene Therapy, Paediatrics.
- Participated in inspection readiness activities including coordination of clinical trial team deliverables.
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.