Clinical Data Enablement, Data Aggregation, Lead

DescriptionClinical Data Enablement, Data Aggregation, LeadAbout Astellas: At Astellas, experience is coupled energised with a relentless challenger spirit. 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 are unusual in our ability to combine the experience, expertise and resources of an established company with the agility, flexibility and tenacity of a start-up. Relentless curiosity and a hunger for discovery flows throughout our entire organisation. We harness the latest technology and insights from big data with our research expertise to create powerful solutions that could transform the way doctors and nurses treat and care for their patients. We are accelerating product development, driving operational efficiencies and gaining a better understanding of the needs of patients and their healthcare providers. We partner and collaborate with academic research institutes and biotechnology companies who share our passion for bringing breakthrough discoveries to patients. 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. Your role reports to the Head, Clinical Data Enablement, Data Science Clinical Data & Information Strategy. Your 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 Responsibilities:

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. 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). Education/Qualifications: BS or MS degree, preferably in Computer Science, Informatics/Data Science, or life science discipline or equivalent. 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.#LI-Dublin#LI-Hybrid#LI-JS1