Field Clinical Specialist

2 weeks ago

Addlestone Surrey, United Kingdom Astellas Pharma Full time

Site Activation Specialist
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. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.
As a Study Start-Up Specialist you will be a local expert in Study Start Up (SSU) activities and strategy including the use of various clinical systems (e.g., CTMS) to enable consistent and compliant forecasting and data collection. IT, IS) by adhering to standard operational terminology and data conventions used for clinical systems.
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. Hybrid work from certain locations may be permitted in accordance with Astellas’ Responsible Flexibility Guidelines.
Supporting the day-to-day operations of assigned activities within SSU to ensure completion per established goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. Ensuring oversight of site level SSU activities from receipt of a potential site list to site activation under the direction of a Global SSU Manager including CDA and questionnaire collection, ICF negotiations, IRB/EC submissions, IMP Release and other site activation requirements.
Generating and providing accurate and up-to-date project status and financial information (where appropriate) within relevant tracking systems/tools.
Leading the preparation of study level essential document templates, aiding in the preparation of content for Regulatory submissions. Fluency in English is required, along with proficiency in either Italian or German. Speakers of Spanish or French are also encouraged to apply.
Good understanding of local SSU processes and requirements.
Proven project management skills.
This is a permanent full-time position.
This position follows our hybrid working model. Role requires a blend of home and a minimum of 1 day per quarter in our local office. Candidates must be located within a commutable distance of the office.
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.
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