Description

You oversee site activities and ensure compliance with study protocols, emphasizing performance, training, and regulatory requirements while supporting enrollment and quality management efforts.

Requirements

• •Minimum 1 year CRA monitoring experience
• •Bachelor’s degree in life science preferred
• •Excellent knowledge of ICH-GCP guidelines
• •Excellent knowledge of local regulations
• •Good medical knowledge of Alexion Therapeutic Areas
• •Good understanding of drug development process
• •Excellent understanding of Clinical Study Management
• •Excellent attention to details
• •Excellent written and verbal communication skills
• •Excellent collaboration and interpersonal skills
• •Good negotiation skills
• •Flexibility in schedule and willingness to travel
• •Valid driving license
• •Solid knowledge of clinical development processes
• •Ability to work in remote collaboration
• •Ability to manage matrix reporting structure
• •Positive approach to managing change
• •Champion efficient methods for clinical trials
• •Ability to prioritize and manage multiple tasks
• •Proactivity in communicating with stakeholders
• •Ability to understand technology impact on projects
• •Team oriented and flexible
• •Experience in all study phases preferred

Tasks

• •Perform site identification, selection, and initiation activities.
• •Monitor site data and conduct closeout visits.
• •Drive site performance and resolve study-related issues.
• •Train and support Investigators and site staff.
• •Develop recruitment plans and manage enrollment.
• •Document recruitment barriers and implement solutions.
• •Ensure monitoring KPIs are met and within quality ranges.
• •Prepare and finalize monitoring visit reports in CTMS.
• •Collect and upload essential documents to the eTMF.
• •Participate in study start-up and regulatory maintenance.
• •Assist with investigator nomination and feasibility activities.
• •Collaborate with Medical Affairs and internal stakeholders.
• •Escalate quality issues and compliance breaches as needed.
• •Prepare for audits and regulatory inspections.