Performing identification, selection, initiation, monitoring, site data review and closeout activities/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 implement 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 eTMF in accordance with ICH-GCP, Alexion SOPs and local requirements. Supporting/participating in regular QC checks of the eTMF
In 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 Global Study team, Local study team, Country Operations Line Management and/or Quality Group, representativesas required.
Preparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with other local team members (e.g., PMCO, , Country Operations Line Management, and Quality Group
Qualifications
Minimum of 1 year of CRA monitoring experience
Bachelor’s degree in related discipline, preferably in life science, or equivalent qualification
Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP.
Excellent knowledge of relevant local regulations.
Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas.
Good understanding of the drug development process.
Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.
Excellent attention to details.
Excellent written and verbal communication skills.
Excellent collaboration and interpersonal skills.
Good negotiation skills.
Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)
Employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours
