Senior Clinical Data Manager

il y a 6 jours

Les Ulis, Île-de-France Ipsen Pharma Temps plein
Job Overview

We are seeking a skilled Clinical Data Manager to join our Ipsen Pharma team. As a key member of our clinical data management team, you will play a critical role in ensuring the high-quality collection, processing, and reporting of clinical data.

About the Role

The successful candidate will have a minimum of 2 years' experience as a Clinical Data Manager in the pharmaceutical industry or a CRO. You will be responsible for overseeing the outsourced clinical data management activities for one or several assigned studies under the supervision of the Principal Clinical Data Scientist. Your primary focus will be on ensuring that clinical data collected, processed, and reported are of high quality, rigorous, objective, and informative.

Main Responsibilities

Your key responsibilities will include:
  • Reviewing the Scope of Work of the Contract Research Organization (CRO) for a given study and supporting purchasing activities
  • Validating proposed budgets and limiting change orders
  • Reviewing Study Synopses/Protocols, Therapeutic Field Leads (TFLs), and Case Report Summaries (CRS)
  • Reviewing and validating data management deliverables from the CRO for a given study (e.g., Data Management Plan/Report, Electronic Data Capture (EDC) Specifications, Edit Check Specifications, Data Transfer Specifications, EDC Completion Guidelines, and Clinical Study Data Package)
  • Creating studies in Ipsen's central data repository and ensuring corresponding clinical study data packages are uploaded accordingly
  • Ensuring the clinical study database meets Ipsen Data Standards requirements, including reviewing annotated CRFs in Ipsen Standard Data Tabulation Model (SDTM) format, database specifications, Pinnacle 21 checks, Reviewer Guides, and Define.xml
  • Ensuring data quality adheres to industry standards and performing quality control on the clinical database (e.g., running SAS Edit Checks, QC of raw data vs. SDTM datasets)
  • Participating in meetings with the CRO and/or study team meetings
  • Ensuring ongoing and timely data review, data reconciliation, and data coding until database lock
  • Ensuring study timelines are met
  • Reporting and escalating issues to the Principal Clinical Data Scientist if any
  • Ensuring adherence to Good Clinical Practice (GCP), regulatory guidelines, and Ipsen SOPs
  • Participating in the continuous improvement of data management processes (e.g., participating in the development of validation tools)


EHS Responsibilities

You will also be responsible for:
  • Complying with applicable EHS regulations and procedures
  • Participating in the site's EHS performance by reporting risks, malfunctions, or improvements
  • Participating in mandatory EHS training


Required Skills and Qualifications

To succeed in this role, you will need:
  • Minimum 2 years' experience as a Clinical Data Manager in the pharmaceutical industry or a CRO
  • Life Science and/or Information Technology degree
  • Proficiency in English (oral and written)


Key Technical Competencies Required

You will need to possess:
  • Knowledge of ICH and GCP guidelines
  • Familiarity with Electronic Data Capture (EDC) and Data Management processes
  • SAS programming skills
  • Understanding of CDISC SDTM standards
  • Quality-focused and attention to detail
  • Excellent organizational and communication skills


Salary

This is a challenging yet rewarding opportunity with a competitive salary range of $80,000 - $110,000 per annum, depending on experience.

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