Job Description:
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The Associate II, TMF Operations role is responsible for ensuring the timely processing and maintenance of essential documents in compliance with regulatory requirements and industry best practices.
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This involves reviewing and resolving rejected Trial Master File (TMF) documents, performing periodic quality control checks, and working with various electronic document management systems.
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* Process and review complex study documents in electronic and hard copy formats;
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* Perform quality control checks to ensure adherence to regulatory standards and industry best practices;
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* Work with electronic document management systems to classify and process essential documents;
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* Communicate directly with RMC Leads to report trends and issues relevant to the TMF;
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* Escalate any quality issues in a timely manner to RMC Leads;
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* Provide administrative support for RMC Leads, including filing and maintaining internal documents on SharePoint;
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Requirements:
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To be successful in this role, you will require:
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* Proficiency in using electronic document repositories or eTMFs and document recognition skills;
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* Strong interpersonal skills in a fast-paced, deadline-oriented environment;
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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, with 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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About the Role:
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This is a global role that requires working with Worldwide Project Team members. The successful candidate will have excellent communication and organizational skills, as well as the ability to work independently and collaboratively as part of a team.
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What You Will Bring:
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We are looking for an individual who can bring the following skills and qualities to this role:
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* Ability to work effectively in a fast-paced environment;
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* Strong analytical and problem-solving skills;
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* Excellent communication and interpersonal skills;
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* Ability to work collaboratively as part of a team;
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* High level of attention to detail and accuracy;
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Why This Role:
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This role offers the opportunity to work in a dynamic and supportive team environment, with the chance to develop your skills and knowledge in a highly regulated industry.
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