Clinical Data Analyst M/F

Responsibilities:Ensure the clinical consistency of data used for statistical analyses and clinical study reports.Clinical data to be checked includes (but is not limited to): laboratory results, adverse events, medical history, vital signs, efficacy measurements, and treatments.Follow up on the resolution of detected issues/inconsistencies via the queries process.Participate in the development and maintenance of core study documents pertaining to the section, e.g., the CRF, CRF Completion Guidelines, Data Validation Specifications, Data Management Plan, Data Review Plan, etc.Ensure Clinical Data Management input to other relevant strategic study documents (i.e., Data Management Operation Plan) and vendor contracts (i.e., central lab data transfer agreement).Detect important medical events.Perform reconciliation of SAE and AE of Special Interest between the Pharmacovigilance database and the Clinical Study Database.Detect forbidden concomitant treatments as per study protocol.Develop and track timelines to ensure data management milestones are met in coordination with the Clinical and Pharmacovigilance Team.Archive documents in the clinical data management TMF.Participate in training and process management within the Clinical Data Review team.Support the Quality Management System (QMS) by participating in the life cycle of procedures and other applicable documents, declaring non-compliances encountered in daily operations, and following the associated corrective and preventive plans, alerting if necessary and suggesting any possible optimizations of the processes.Function as section representative in audits and regulatory inspections.Ensure the completion of MedDRA and WHODD Coding of medical terms and concomitant medications in a timely manner, following company guidelines.Increase functional effectiveness by supporting departmental efforts to simplify and standardize procedures, sharing best practices, and participating in or leading continuous improvement efforts.Facilitate and/or participate in management and functional area meetings, contributing expertise when necessary through formal or informal presentations.Support the database programming aspect of the data review plan, including programming of data review reports and regulatory documents.Requirements:Male or female with a University degree (MSc or PhD) in Pharmacy, Pharmacology, Life Sciences, or a related discipline.At least 5 years of experience in Clinical trials, preferably in Clinical Data Management.Knowledge of the clinical development process.Understanding of regulatory guidelines in a pharmaceutical research setting, including ICH GCP training.Sound familiarity with Office automation tools (i.e., Excel, Word, PowerPoint).Knowledge of database programming tools is a plus (i.e., SQL, MS Access, SAS, etc.).MedDRA coding certification is a plus.WHODD coding certification is a plus.Based in Paris.Salary & package to be defined according to skills and experience. #J-18808-Ljbffr