Overview
Site Activation Specialist – Astellas Pharma
About Astellas: At Astellas we are a progressive health partner, delivering value and outcomes where needed. We pursue innovative science, focusing on areas of greatest potential and 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 with patients, doctors and health care professionals to ensure patient and clinical needs guide our development activities. Our global vision for Patient Centricity supports the development of innovative health solutions through a deep understanding of the patient experience. We work closely with regulatory authorities and payers to ensure access to new therapies and to provide meaningful outcomes for patients and their care-givers. This role sits within Clinical Operations Excellence (COE) and is based in Spain. The role offers a hybrid working model with time in the office and from home in line with guidelines.
The Opportunity As a Study Start-Up Specialist you will be a local expert in Study Start Up (SSU) activities and strategy, including the use of clinical systems (e.g., CTMS) to enable consistent and compliant forecasting and data collection. You will work within Clinical Operations in both early and late stages and with partnering functions (e.g., IT, IS) by adhering to standard operational terminology and data conventions used for clinical systems. This role is site facing and will support the global SSU team by efficiently managing and tracking assigned site activations, and providing administrative support related to clinical systems/technology used by Clinical Operations. This position has no direct reports.
Responsibilities
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. This includes effective communication and coordination with key business stakeholders to support timely completion of drug and non-drug program goals and objectives.
Identifying and escalating issues related to SSU deliverables and effectively executing against assigned SSU activities.
Overseeing 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 content for Regulatory submissions, handling ICF negotiations, and facilitating escalations; involved in the preparation and submission of IMP Release Packages.
Essential Knowledge & Experience
Extensive clinical trial experience and clinical trial conduct.
Good understanding of local SSU processes and requirements.
Proficient in English and the primary language of the country of employment.
General knowledge of drug development and ICH/GCP guidelines.
Proven project management skills.
Education/Qualifications
BA/BS degree in life science or equivalent.
Preferred Experience
Worked cross-functionally and within matrix teams.
Involved in early development studies.
Additional Information
This is a permanent full-time position.
This position is based in Spain.
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. Flexibility may be required in line with business needs. 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.
Seniority level
Entry level
Employment type
Full-time
Job function
Information Technology
Industries
Pharmaceutical Manufacturing
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