Performing selection, initiation, interim monitoring and closeout visits (remote and onsite), 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.

Proactively identifying and ensuring timely resolution to study-related issues and escalates them as appropriate.

Training, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principles.

Development of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones.

Document recruitment barriers and mitigation plans.

Ensure agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges (Action Items aging, SDV metrics, Data entry metrics, query aging, MV reports metrics, etc.)Preparing and finalizing monitoring visit reports in CTMS and provide timely feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with Alexion SOPs.

Ensuring timely collection/uploading of essential documents into the e TMF in accordance with ICH-GCP, Alexion SOPs and local requirements.

Supporting/participating in regular QC checks of the e TMFIn some countries, as required, CRAs are accountable for study start-up and regulatory maintenance.

Tasks may include collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the study.

Contributing to the nomination and selection of potential investigators and assisting with feasibility activities Collaborating with local Medical Affairs, 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 Quality Group as required.

Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with PMCO, SML, COLM and Quality Group.

Date Posted31-Jul-2024 Closing Date Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer.

We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness.

The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law.

Alexion provides reasonable accommodations to meet the needs of candidates and employees.

To begin an interactive dialogue with Alexion regarding an accommodation, please contact.

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