Job Description:
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* The primary objective of this role is to ensure the processing, maintenance, and archiving of all essential documents in compliance with relevant Standard Operating Procedures (SOPs), ALCOA principles, country regulations, and industry best practices.
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* This individual will support the delivery of department objectives by ensuring the management of essential documents, working closely with Worldwide Project Team members in a global capacity.
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Key Responsibilities:
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1. To process, review, and resolve rejected Trial Master File (TMF) documents in both electronic and hard copy formats for complex studies or Sponsor portfolios.
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2. To perform periodic TMF Quality Control to ensure adherence to regulatory, ICH GCP, Sponsor, and industry best practices.
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3. To work with various Electronic Document Management and electronic TMF Systems to review, classify, and process Essential Documents.
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4. To communicate directly with the RMC Lead to report trends and issues relevant to the TMF, escalating any quality issues in a timely manner.
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5. To provide administrative support for the RMC Lead, including filing and maintaining internal documents on study SharePoint (TMF Quality Control checklists and different trackers).
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Required Skills and Qualifications:
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* Proficiency in using an electronic document repository or eTMF, as well as document recognition skills.
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* Strong interpersonal skills in fast-paced, deadline-oriented environments with rapidly changing requirements.
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* Sound judgment and ability to identify decisions requiring supervisory approval.
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* Proficiency in Microsoft Word and Excel.
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* University Degree preferred (Life Science desirable).
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* 1-2 years of relevant experience.
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* Knowledge of working within a highly regulated industry (desirable).
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Benefits:
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This role offers a unique opportunity to contribute to the success of the organization while developing valuable skills and expertise.
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As a member of the team, you will have the chance to work collaboratively with experienced professionals and learn from their expertise.
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The ideal candidate will possess excellent communication and problem-solving skills, with the ability to adapt to changing priorities and deadlines.
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We are committed to providing a supportive and inclusive work environment that fosters growth and development.