Responsabilities
  • Ensure the clinical consistency of data used for statistical analyses and clinical study reports
  • Clinical data to be check includes (but not limited to): laboratory results, adverse events, medical history, vital signs, efficacy measurements and treatments.
  • Follow-up the resolution of detected issues/inconsistencies via queries process
  • Participate to 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 the 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 to the training and process management within the Clinical Data Review team.
  • Support the Quality Management System (QMS) by participating in the life cycle of procedure and other applicable documents, declaring non-compliances encountered in the daily operations and following the associated corrective and preventive plans, alerting if necessary and suggesting any possible optimization 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, and, by following the 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 University degree (MSc or PhD) in Pharmacy, Pharmacology, Life Sciences or related discipline.
  • At least 5 years of experience in Clinical trials, preferably in Clinical Data Management.
  • Knowledge of clinical development process.
  • Understanding of regulatory guidelines in a pharmaceutical research setting, including ICH GCP training.
  • Sound familiarity with Office automation tool (i.e. Excel, Word, Power point)
  • Knowledge of database programming tool is a plus (i.e. SQL, MS Access, SAS, etc.)
  • MedDRA coding certification is a plus
  • WHODD coding certification is a plus
Additionnal informations
  • Permanent position, available immediately
  • Based in Paris
  • Salary & package to define according skills and experience