Job Highlights
Not Disclosed
Posted 1 year ago
Job details
#IpsenTraineeSquad
Purpose of the mission
ETMFs Quality Control
Education: Minimum B.A./B.S. degree in science/healthcare field required
Desire to help others.
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.
- Perform eTMF or data archiving activities in the IPSEN systems.
- Manage eTMF / data transfers from external partner into Ipsen Systems.
- 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.
- Perform testing activities when needed.
- Act as the back-up of the other eTMF Systems Administrators as reasonably required.
- 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.
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.
Desire to help others.
- Ability to communicate effectively and develop positive relationships with a wide variety of people.
- Fluent English & French
- 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
Location:
- France
Global Experience Needed?
- No
Specialized Experience Needed?
- No
Apply before:
- Apr 12, 2024
Company Overview
Ipsen
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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