Job Specifications
Description
Clinical Trial Manager
About Astellas
At Astellas we are a progressive health partner, delivering value and outcomes where needed.
We pursue innovative science, focussing 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 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 quality of trial deliverables.
This position is based in the UK.
Hybrid Working
At Astellas we recognise 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 optimise 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 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
Proven EU-CTR and in-sourced study management 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
Sponsor side experience in Oncology (ideally) or Rare Diseases, Gene Therapy, Pediatrics.
Facilitated site engagement and communications with investigators and/or staff to support trial milestones and deliverables.
Demonstrated vendor management experience.
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.
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About the Company
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Visit our Global Astellas LinkedIn Community Guidelines to learn more about interacting with this page: https://www.astellas.com/en/global-linkedin-community-...
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