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 the Clinical Data Enablement (CDE) Data Aggregation Lead you will establish the data flow from source vendors to Astellas for Phase I-IV clinical trials executed by Astellas and transform that data for data review and cleaning purposes while also ensuring that these data are able to be shared to internal Astellas consumers following an established dataflow.
This role reports to Head, Clinical Data Enablement, Data Science Clinical Data & Information Strategy.
This position is based in the UK or Republic of Ireland.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver. Candidates interested in remote work are encouraged to apply.
Key Activities for this Role:
- Enabling the data flow for Phase I-IV clinical trials consistent with aligned commitments inclusive of data ingest, transformation and internal availability of this data for data review, data cleaning and readiness for data analysis.
- Working directly with vendors providing source data (i.e. vendors providing lab results, ECGs, biomarkers, etc.) and/or internal functions such as clinical operations or early development to ensure that related specifications, mechanisms for data transfers and data transfer schedules are established and executed appropriately.
- Contributing to related technical and/or process improvement initiatives associated with the clinical results data flow and efforts within the department and across Astellas broadly.
- Collaborating cross functionally with areas performing data management, clinical operations, IT support, etc. to address any issues with the delivery or stability of the clinical data flow as appropriate.
Essential Knowledge & Experience:
- Prior pharma or CRO industry experience working on global clinical studies and projects or global process and system initiatives.
- Experienced with systems and processes that include an end-to-end data flow and the transformation of data in support of data review and/or data cleaning.
- Strong verbal and written communication skills.
- Demonstrated experience collaborating with others to achieve an objective.
- Familiarity with all phases of clinical development.
Education:
- BS or MS degree, preferably in Computer Science, Informatics/Data Science, or life science discipline or equivalent.
Preferred Experience:
- Experienced in using at least one programming language (i.e. R, Python, SAS, SQL, etc).
- Demonstrated ability and experience in leading global process or system improvement projects.
- Knowledge of data standards in industry (CDISC, CDASH).
Additional Information:
- This is a permanent full-time position.
- Limited travel requirement <5%.
- Primarily based in the UK or Republic of Ireland.
- 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.
Beware of recruitment scams impersonating Astellas recruiters or representatives. Authentic communication will only originate from an official Astellas LinkedIn profile or a verified company email address. If you encounter a fake profile or anything suspicious, report it promptly to LinkedIn's support team through LinkedIn Help.
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