Job Title: eTMF Specialist
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Description:
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We are seeking a highly skilled eTMF Specialist to join our team. The successful candidate will be responsible for leading the Documentation and Data Archiving team, ensuring that data management and statistics trial documentation is managed according to internal standards and regulatory requirements.
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Main Responsibilities:
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* To ensure data management and statistics trial documentation is managed according to internal standards and regulatory requirements.
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* To oversee activities to ensure TMF documentation is published in a timely manner and with high quality in order to maintain TMF in an inspection and audit readiness.
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* To lead the Documentation and Data Archiving team providing subject matter expertise and guidance to team members.
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* To ensure providers match performance expectations.
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* To promote optimal use of tools and metrics related to documentation management.
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Requirements:
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* Scientific degree.
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* A 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 skills.
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* eTMF - EDMS - SAS System.
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About this Role:
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This is an exciting opportunity for a motivated and experienced professional to join our team as an eTMF Specialist.
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What We Offer:
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* An opportunity to work on challenging projects and contribute to the success of our organization.
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* The chance to develop your skills and expertise in eTMF and related areas.
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* A collaborative and dynamic work environment.
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* Competitive salary and benefits package.
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How to Apply:
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Please submit your application if you are a motivated and experienced professional looking for a new challenge.