Clinical Data Analyst M/F

Responsibilities

• 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
• Based in Paris
• Salary & package to define according skills and experience