Etmf And Data Archiving - Parma - Novasyte

Descrizione

Job Title: eTMF and Data Archiving Specialist

We are seeking a highly skilled eTMF and Data Archiving Specialist to join our dynamic team in a global pharmaceutical company. The successful candidate will be responsible for ensuring data management and statistics trial documentation meets internal standards and regulatory requirements.

The ideal candidate will have a scientific degree, significant experience in a similar role in the industry or CRO, and knowledge of drug development process, clinical data management, and statistical process.

The key responsibilities of this role include leading the documentation and data archiving team, recruiting, mentoring, and developing the team members. Additionally, the successful candidate will train DM/STAT CRO on Company standards and TMF related activity, monitor TMF related activities using metrics, and participate in audits and inspections.

To be successful in this role, the candidate should have strong knowledge of international standards for Trial Master File (TMF Reference Model), ICH GCP, and regulatory requirements with specific reference to data integrity, data archiving, and document management.

We offer a challenging and dynamic work environment, and we are looking for someone who is passionate about pushing the boundaries of human science and data science to make a meaningful impact in the life sciences industry.

Key Requirements:

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• Scientific degree
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• Significant experience in a similar job in the industry or CRO
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• Knowledge of drug development process
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• Solid knowledge of clinical data management and statistical process and related documentation, standards, and tools
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• Strong knowledge of international standards for Trial Master File (TMF Reference Model)
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• Knowledge of ICH GCP and regulatory requirements with specific reference to data integrity, data archiving, and document management
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• Good knowledge of SAS System
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• Knowledge of international data standards (CDISC) and regulatory requirements for data submission
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• Project and budget management
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• English language proficiency
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• eTMF - EDMS - SAS System
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Type of Contract: Maternity replacement
Chemical contract