Study coordinator Jobs in Hamburg

Study Start-Up 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 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 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. You will work within Clinical Operations in 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 role will be site facing and 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 utilised 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 (e.g., study teams) to support timely completion of both drug and non-drug program goals and objectives.
• Identifying and escalating issues that arise related to support SSU deliverables and effectively executing against assigned activities within SSU.
• 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. Handling ICF negotiations and facilitating any required escalations and involved in the preparation and submission of IMP Release Packages.

Essential Knowledge & Experience :

Education / Qualifications :

Preferred Experience :

Additional Information :

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.