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AB Science is hiring a Clinical Data Analyst based in Paris. Responsibilities cover clinical data consistency, medical coding, document management, and protocol compliance, among others. The role supports QMS, continuous improvement, and collaboration with cross-functional teams. Candidates should hold a MSc or PhD and have at least 5 years of Clinical Data Management experience.
Job Responsibility:
Ensure the clinical consistency of data used for statistical analyses and clinical study reports
Clinical data to be check includes 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
Ensure Clinical Data Management input to other relevant strategic study documents and vendor contracts
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 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
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
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
Nice to have:
Knowledge of database programming tool (i.e. SQL, MS Access, SAS)
MedDRA coding certification
WHODD coding certification
What we offer:
Permanent position
Salary & package to define according skills and experience
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