General Information
Job Advert Title Manager, Clinical Operations Systems Location Poland Function/Business Area Missing req details TBC Employment Class PermanentDescription
Manager, Clinical Operations SystemsAbout 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 Manager, Clinical Operations Systems, you will be tactically accountable for managing activities related to system implementation, training, and system-related business and clinical operations processes utilised by the Function Unit. This will include processes and systems related to clinical study execution.
Primary responsibility will include optimizing the clinical execution model design, standards, and tools to be used by the clinical operations teams. Visualization tool management, change management tactics, and communication strategies to ensure a harmonized clinical operations model is available for the organization will be key.
You will work closely with internal and external customers as well as business partners to provide tactical support and ensure the execution of clinical operations on time and within budget.
This position requires strong global and cross-functional collaboration and a lens towards optimizing the clinical operations model in an evolving organization.
Hybrid Working:
At Astellas we recognise the importance of balancing your work and home life, so we offer a hybrid working solution allowing time to connect with colleagues in person at the office alongside the flexibility to work from home; optimising the most productive work environment for you to succeed and deliver.
Key Responsibilities:
- Support new technology deployment and establishing data quality standards/ oversight.
- Support successful execution of training to functional team members on clinical systems and related processes.
- Support identification of new technology needs, technology budget evaluation, and business case development to launch technologies for the Functional Unit.
- Support business requirement specification development for new systems or system enhancements and ensure successful engagement with other cross-functional stakeholders.
Essential Knowledge & Experience:
- Expert knowledge with clinical trial operational data and applications, with preferred administration level support in operational applications.
- Knowledge of data flows and data integrations for operational data (milestones, reference data, or site data), including CRO operations data.
- Experience liaising with stakeholders for specification document requirements.
- Experienced in measuring and managing data quality metrics and compliance.
Preferred Knowledge & Experience:
- Experience with enterprise system implementation or major enhancement build-out.
- Experience as a UAT tester, including authoring test scripts or preparing UAT data.
- Experience with authoring of aids, process documents, and user training.
- Familiarity with System Lifecycle Management processes and documentation.
- System alignment experience with mappings to enable integrations across different clinical systems such as CTMS, EDC, Payment Solution, IRT.
- Experience with the specification or development of user dashboards and reports.
Education/Qualifications:
- Bachelor’s degree or equivalent.
Additional Information:
- This is a permanent, full-time position.
- This position is based in Poland.
- This position follows our hybrid working model. Role requires a blend of home and a minimum of 2 days per week in our Warsaw office. Flexibility may be required in line with business needs.
We are an equal opportunity employer, and all qualified applicants will receive consideration foremployment 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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