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 country team(s), working in close collaboration with other CRAs and the Country Operations Management (COM) Team to ensure that study commitments are achieved in a timely and efficient manner.The Sr.CRA acts as the main contact with the study site and has the responsibility for monitoring the study conduct to ensure proper delivery and compliance of the study, being also 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 and that the sites deliver according to their respective commitment in the individual studies.A Sr. CRA with demonstrated skillset and experience may take on additional responsibilities and tasks as needed (eg. Lead CRA, etc).Responsible for: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 appropriateTraining, supporting and advising Investigators and site staff in study related matters, including Risk Based Quality Management (RBQM) principlesDevelopment of recruitment plans with each site and managing and supporting enrollment to ensure sites and studies meet enrollment milestones. Document recruitment barriers and mitigation plansEnsure 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 SOPsEnsuring 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 eTMFIn 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 studyContributing to the nomination and selection of potential investigators and assisting with feasibility activitiesCollaborating with local Medical Affairs and other internal stakeholders, as neededFollowing quality issue processes by escalating systematic or serious quality issues, data privacy breaches, or ICH-GCP compliance issues to SLCO, SML, PMCO and/or Quality Group as requiredPreparing for and collaborating with the activities associated with audits and regulatory inspections in liaison with SML and Quality GroupRequirements:Minimum of 4 years of CRA monitoring experienceBachelor's degree in related discipline, preferably in life science, or equivalent qualificationAdvanced level of English requiredExcellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDPExcellent knowledge of relevant local regulationsGood medical knowledge and ability to learn relevant Alexion Therapeutic AreasGood understanding of the drug development processExcellent understanding of Clinical Study Management including monitoring, study drug handling and data managementExcellent attention to detailsExcellent written and verbal communication skillsExcellent collaboration and interpersonal skillsGood negotiation skillsAbility to work in an environment of remote collaborators and in a matrix reporting structureManages change with a positive approach for self, team and the business Sees change as an opportunity to improve performance and add value to the businessAbility to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less timeDemonstrates ability to prioritize and manage multiple tasks with conflicting deadlinesProactivity and assertivity when communicating with internal stakeholders and sitesAbility to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environmentTeam oriented and flexible; ability to respond quickly to shifting demands and opportunitiesExperience in all study phases and in rare medical conditions preferred.Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)Valid driving license (*)Date Posted13-mar-2024Closing Date13-abr-2024
