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Clinical Trial Document Management Specialist

On-site Full-time

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Experience Level

Mid to Senior

Qualifications

Bachelor’s degree is preferred.3-5 years of experience in clinical trial document management and regulatory documentation is required. Familiarity with electronic trial master file systems, including document uploading, reviewing, and quality control. In-depth understanding of the clinical study process and ICH/GCP guidelines. Strong computer skills to enhance efficiency in daily tasks. Excellent verbal and written communication skills. Ability to work collaboratively in a diverse international team environment. Willingness to train others in study administration procedures. Exceptional organizational and time management skills, with a keen eye for detail and the ability to multi-task in a fast-paced environment. Integrity and a strong commitment to ethical standards.

About the job

Join our dynamic team at US Tech Solutions as a Clinical Trial Document Management Specialist. In this pivotal role, you will be responsible for ensuring the integrity and compliance of clinical trial documentation. Your expertise will support the setup and maintenance of Trial Master Files (TMFs) and Investigator Site Files (ISFs), enabling our clinical trials to operate smoothly and efficiently.

  • Assist in establishing and managing the local Trial Master File (eTMF) and Investigator Site File, ensuring adherence to ICH/GCP guidelines and local requirements.
  • Collaborate with Clinical Research Associates (CRAs) for the maintenance and closure of ISFs.
  • Contribute to the creation and upkeep of study documents, adhering to template and version compliance.
  • Input clinical-regulatory documents into the Global Electronic Library (GEL) while ensuring compliance with the Client Authoring Guide.
  • Support electronic submissions by managing clinical-regulatory documents according to Submission Ready Standards (SRS).
  • Maintain and accurately populate information in client tracking and communication tools like IMPACT and SharePoint.

About US Tech Solutions

US Tech Solutions is a leading global staff augmentation firm dedicated to providing a wide range of talent on demand and comprehensive workforce solutions. We are constantly seeking skilled professionals to meet the evolving staffing needs of our clients. Our mission is to foster mutual growth for both individuals and organizations, making a positive impact on careers and businesses alike. For more information, please visit www.ustechsolutions.com.

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