ETMF Specialist H/F

Hiring By - Biostaffic



Job Highlights

Not Disclosed

Posted 4 months ago
Job details
Purpose of the mission
ETMFs Quality Control
  • Perform quality control of Sponsor documents submitted to the eTMF using the established acceptable criteria.
  • Complete the QC workflow in either approving document or raising a quality issue to the document owner.
  • Ensure documents which fail TMF quality control and/or TMF quality review are effectively remediated and provide best practice recommendations.
  • Monthly, extract list of duplicate documents
  • Create quality issue and send it to the individual who has loaded the duplicated document asking review and deletion if applicable.
  • Analyze/produce reports and dashboards to provide insights on the eTMF to the study team members.
  • Ensure Essential Document Lists (EDLs) are maintained on an ongoing basis.
ETMFs Archiving /transfers
  • Perform eTMF or data archiving activities in the IPSEN systems.
  • Manage eTMF / data transfers from external partner into Ipsen Systems.
Provide Trainings To Systems Users (eTMF)
  • Conduct system training sessions and maintain training documentation and user guides.
  • Create and provide new user guides and training materials as needed (example: eTMF KPI related to CRO activities)
  • Collect feedback on learning materials and request updates as needed.
ETMF Administration
  • Perform testing activities when needed.
  • Act as the back-up of the other eTMF Systems Administrators as reasonably required.
EHS Responsibilities
  • Comply with applicable EHS regulations and procedures.
  • Participate in the site's EHS performance by reporting risks, malfunctions or improvements.
  • Participate in mandatory EHS training.
Experience / Qualifications
Education: Minimum B.A./B.S. degree in science/healthcare field required
  • 2+ years of relevant clinical research and TMF experience at a biotechnology, pharmaceutical company or CRO required.
  • Previous experience working in eTMF system software; experience in Veeva Vault eTMF system software preferred.
  • Solid understanding of the clinical trial process.
  • Experience in handling clinical trial related documents required and knowledge of Trial Master File Reference Model Structure standard.
  • Strong knowledge of ICH-GCP guidelines and regulatory requirements related to clinical document management.
  • Demonstrated ability to understand and comply with ALCOA+ standard, Good Clinical Practice (GCP), Good Documentation Practices, and International Council for Harmonization (ICH) E6(R2) guidelines.
  • Excellent oral and written communication skills.
Ability to produce high quality, accurate work to meet deadlines.
Desire to help others.
  • Ability to communicate effectively and develop positive relationships with a wide variety of people.
  • Fluent English & French
Key Technical Competencies Required
  • Good Knowledge of VEEVA eTMF
  • Good Knowledge of TMF reference model
  • Good knowledge of international standards (ICH, GCP, GAMP …)
  • Up to date on regulations regarding clinical data collection such as: GCP (Good Clinical Practice), 21 CFR part 11, GCDMP (Good Clinical Data Management Practices) and GDPR (General Data Protection Regulation)

Benefits Offered?

  • No

Bonus Offered?

  • No

Travel Required?

  • No


  • France

Global Experience Needed?

  • No

Specialized Experience Needed?

  • No

Apply before:

  • Apr 12, 2024
Company Overview

Current Openings: 0

Ipsen is a French leading global mid-size biopharmaceutical company headquartered in Paris, France focusing its efforts where unmet medical needs are greatest. Ipsen develops and commercializes innovative medicines in three key therapeutic areas - Oncology, Rare Disease and Neuroscience. We have over 5000 employees worldwide and our medicines are registered in more than 100 countries, with direct commercial presence in over 30 countries. Ipsen has 4 global R&D hubs and 3 pharmaceutical development centers around the world.
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