Senior Clinical Research Associate

This Is What You Will Do

• Local responsibility for the delivery of studies at allocated sites.
• Active participant in the local study team(s).
• Works in close collaboration with Project Management Clinical Operations (PMCO), Study Start-Up (SSU) manager, Clinical Study Assistant (CSA) and other CRAs in Country Operations Management (COM).
• Makes sure study commitments are achieved in a timely and efficient manner.
• Ensures proper delivery and compliance of the study.
• Selects, initiates, monitors, and closes assigned sites in clinical studies.
• Monitors and evaluates the performance of study sites.
• Trains, supports, and advises Investigators and site staff in study-related matters.
• Develops recruitment plans with each site and manages and supports enrollment to ensure sites and studies meet enrollment milestones.
• Documents recruitment barriers and mitigation plans.
• Ensures agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges.
• Prepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator.
• Ensures timely collection/uploading of essential documents into the eTMF.
• Supports/participates in regular QC checks of the eTMF.
• May be accountable for study start-up and regulatory maintenance.
• Contributes to the nomination and selection of potential investigators and assists with feasibility activities.
• Collaborates with local Medical Affairs, Medical Advisor Pipeline (MAP) and other internal stakeholders.
• Follows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues.
• Prepares for and collaborates with activities associated with audits and regulatory inspections.

You Will Need To Have

• A minimum of 4 years of CRA monitoring experience.
• A Bachelor's degree in a 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.
• Excellent understanding of Clinical Study Management including monitoring, study drug handling and data management.
• Excellent attention to detail.
• 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).
• Ability to work in an environment of remote collaborators and in a matrix reporting structure.
• Manages change with a positive approach for self, team and the business.
• Sees change as an opportunity to improve performance and add value to the business.
• Ability to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less time.
• Prioritizes and manages multiple tasks with conflicting deadlines.
• Proactive and assertive when communicating with internal stakeholders and sites.
• Understands the impact of technology on projects and uses and develops computer skills while making appropriate use of systems/software in an e-enabled environment.
• Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities.
• Experience in all study phases and in rare medical conditions preferred.