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.
Job Tags
Remote work,
Similar Jobs
My3Tech
Requirements: Certified Scrum Master Strong Digital Marketing background/projects Azure DevOps experience (ADO) PMP preferred not required
Amazon Kuiper Manufacturing Enterprises LLC
...the U.S. as a refugee or granted asylum. We are looking for an experienced Satellite Test Engineer to help architect next generation test infrastructure and lead Integrated Vehicle test campaigns. Our team is responsible for development and implementation of test...
Cedars Healthcare Center
...approved COVID-19 vaccination, as well as any subsequent booster doses, as recommended by the Centers for Disease Control and Prevention (CDC). To facilitate and further encourage COVID-19 vaccinations, Stellar periodically organizes onsite vaccination clinics at its various...
Genesis of Edmond
Ted Moore Auto Group is always looking for top-tier management talent. If you have experience managing in the automotive industry, we are currently looking for a Parts Manager.As a Parts Manager at Ted Moore Auto Group, you will enjoy a fun, fast-paced work environment...
Michigan Medicine
...that directly relate to this position. Job Summary We are looking for a personable, self-motivated, and organized Clinical Research Assistant to help with recruitment activities for a large, multi-year clinical trial testing the efficacy of behavioral interventions...