Job Description
Position Title: Clinical Documentation Specialist II
100% remote
+ Manage Phase I to IV study activities.
+ Ensures the Master File is always inspection-ready and complies with ICH GCP guidelines.
+ This role involves regularly updating and assisting study teams to address issues related to key Master File health indicators, including the completeness, accuracy, and timeliness of all essential documents throughout the lifecycle of assigned clinical trials.
+ Ensures the Master File is always inspection-ready and complies with ICH GCP guidelines.
+ This role involves regularly updating and assisting study teams to address issues related to key Master File health indicators, including the completeness, accuracy, and timeliness of all essential documents throughout the lifecycle of assigned clinical trials.
+ Bachelor's degree or international equivalent preferred. Minimum 2 years relevant industry experience in clinical document management or equivalent experience preferred.
+ Demonstrates analytical and critical thinking skills.
+ Excellent oral and written communication skills; ability to facilitate cross-functional team meetings.
+ Demonstrates awareness of clinical documentation business procedures. Compliant to clinical documentation processes
+ Experienced in using Microsoft PowerPoint and Excel &/or Document Management Systems preferred.
About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
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