Study Start-Up Specialist
Study Start-Up Specialist
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Job Description
Job Title: Study StartUp Specialist
Job Location: Great Britain United Kingdom
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: Associate
Study StartUp Specialist
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 underserved disease areas and in lifethreatening or lifelimiting 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 patientcentric 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 realworld evidence to inform the best decisions for patients and their caregivers 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 a Study StartUp Specialist you will be a local expert in Study StartUp (SSU) activities and strategy including using various clinical systems (e.g. CTMS) to enable consistent and compliant forecasting and data collection. You will work within Clinical Operations both early and late and with partnering functions (e.g. IT IS) by adhering to standard operational terminology and data conventions used for clinical systems.
This sitefacing role will support the global SSU team by efficiently managing and tracking assigned site activations. You will also provide administrative support related to various clinical systems/technology utilized by Clinical Operations. This position has no direct reports.
Key Responsibilities:
- Supporting the daytoday 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 (e.g. study teams) to support the timely completion of both drug and nondrug program goals and objectives.
- Identifying and escalating issues that arise related to supporting SSU deliverables and effectively executing against assigned activities within SSU.
- Ensuring oversight of sitelevel 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 uptodate project status and financial information (where appropriate) within relevant tracking systems/tools.
- Leading the preparation of studylevel essential document templates aiding in the preparation of content for Regulatory submissions handling ICF negotiations and facilitating any required escalations and being 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.
Preferred Experience:
- Worked crossfunctionally and within matrix teams.
- Involved in early development studies.
Education/Qualifications:
- BA/BS degree in life science or equivalent.
Additional Information:
- This is a permanent fulltime position.
- This position is based in the UK France Germany Italy Spain and Poland.
- This position is 100% home/remote.
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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Employment Type
Full Time
