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Clinical Data Analyst

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AB SCIENCE

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Location:
France , Paris

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Category:
Pharmacy

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Contract Type:
Employment contract

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Salary:

Not provided
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Job Description:

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

Additional Information:

Job Posted:
December 01, 2025

Employment Type:
Fulltime
Work Type:
On-site work
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