[Alexion] Sr. Clinical Research Associate

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About the role

This is what you will do: • The Senior Clinical Research Associate (Sr. CRA) has local responsibility for the delivery of the studies at allocated sites and is an active participant in the local study team(s). The Sr. CRA works in close collaboration with Project Management Clinical Operations (PMCO), the Study Start-Up (SSU) Manager, Clinical Study Assistant (CSA) and other CRAs in Clinical Operations Management (COM) to ensure that study commitments are achieved in a timely and efficient manner at the country level. The Sr. CRA acts as the main contact for the study site and is responsible for monitoring the study conduct to ensure proper delivery and compliance. • The Sr. CRA is responsible for the selection, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with Alexion Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations while ensuring that sites deliver according to their respective commitment in individual studies. • A Sr. CRA with demonstrated skills and experience may take on additional responsibilities and tasks as needed, such as serving as a Lead CRA. You will be responsible for: • Performing selection, initiation, interim monitoring, and closeout visits, both remotely and on-site, as well as remote data checks, in accordance with the timelines specified in the study-specific Clinical Monitoring Plan (CMP). • Driving performance at the sites by proactively identifying study-related issues, ensuring their timely resolution, and escalating them as appropriate. • Training, supporting, and advising investigators and site staff on study-related matters, including Risk-Based Quality Management (RBQM) principles. • Developing recruitment plans with each site and managing and supporting enrolment to ensure that sites and studies meet enrolment milestones. Documenting recruitment barriers and mitigation plans. • Ensuring that agreed monitoring KPIs are monitored and remain within the agreed acceptable quality ranges, including action-item ageing, data-entry metrics, query ageing, and MV report metrics. • Preparing and finalising monitoring visit reports in the CTMS and providing timely feedback to the Principal Investigator, including the follow-up letter, within the required timelines and in line with Alexion SOPs. • Ensuring the timely collection and uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs**,** and local requirements, and supporting or participating in regular QC checks of the eTMF. • Supporting study start-up and regulatory maintenance, where required. Tasks may include the collection, preparation, review, and tracking of documents for the application process, as well as the submission of appropriate applications and documents to the EC/IRB and Regulatory Authorities for start-up and throughout the study. • Contributing to the nomination and selection of potential investigators and assisting with feasibility activities**.** • Collaborating with local Medical Affairs, the Medical Advisor Pipeline (MAP), and other internal stakeholders, as needed. • Following quality-issue processes by escalating systematic or serious quality issues, data-privacy breaches, or ICH-GCP compliance issues to SLCO, SML, PMCO, COML, HCO**,** and/or the Quality Group, as required. • Preparing for and collaborating on activities associated with audits and regulatory inspections, in liaison with PMCO, SML, COML, and the Quality Group. You will need to have: • A minimum of 4 years of CRA monitoring experience. • A bachelor's degree in related discipline, preferably in life sciences, or equivalent qualification. • Excellent knowledge of international guidelines, including ICH-GCP, and basic knowledge of GMP/G

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