Clinical Data Analyst M/F

AB Science; Paris; Sur place; EUR 70 000 - 100 000; Plein temps

Résumé du poste

A pharmaceutical company based in Paris is seeking a Clinical Data Manager to ensure the clinical consistency of data for statistical analyses and study reports. The ideal candidate has a MSc or PhD in Life Sciences, at least 5 years of experience in clinical trials, and familiarity with regulatory guidelines. Strong organizational skills and knowledge of database programming tools are preferred. The position offers a competitive salary package based on skills and experience.

Qualifications

• At least 5 years of experience in Clinical trials, preferably in Clinical Data Management.
• Sound familiarity with Office automation tools like Excel, Word, and PowerPoint.
• Knowledge of database programming tools is a plus.
• Understanding of regulatory guidelines in a pharmaceutical research setting, including ICH GCP training.
• Sound familiarity with Office automation tool (Excel, Word, PowerPoint).
• Knowledge of database programming tool is a plus (SQL, MS Access, SAS).
• MedDRA coding certification is a plus
• WHODD coding certification is a plus
• Based in Paris
• Salary & package to define according skills and experience.

Responsabilités

• Ensure the clinical consistency of data for analyses and reports.
• Participate in developing core study documents and vendor contracts.
• Support the Quality Management System by declaring non-compliances.
• Participate in development and maintenance of core study documents (e.g., CRF, Data Validation Specifications, DMP).
• Ensure CDM input to Data Management Operation Plan 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 forbidden concomitant treatments as per study protocol.
• Develop and track timelines to meet data management milestones with teams.
• Archive documents in the clinical data management TMF.
• Participate in training and process management within the CDM team.
• Support the QMS by contributing to procedures and CAPAs, flagging non-compliances.
• Represent the section in audits and inspections.
• Ensure MedDRA/WHODD coding timely and compliant with guidelines.
• Improve procedures by sharing best practices and leading improvements.
• Support data review reports and regulatory documents programming.

Connaissances

Clinical trials experience

Office automation tools

Understanding of regulatory guidelines

Database programming

Database programming tools knowledge

Formation

MSc or PhD in Pharmacy, Pharmacology, Life Sciences

Outils

SQL

MS Access

SAS

Description du poste

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