Etmf Specialist

#IpsenTraineeSquad_

**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.

Langages:

- 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)

**#LI-Hybrid