Planet Pharma
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https://www.propharmagroup.com
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Clinical Documentation Specialist II
Posted: 04/08/2025
2025-04-08
2025-05-19
Employment Type:
Contract
Job Category: Clinical Development and Operations
Job Number: 618965
Is job remote?: Yes
Country: United States
Job Description
Target PR Range: 28-38/hr
*Depending on experience
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.
1. Bachelor's degree or international equivalent preferred. Minimum 2 years relevant industry experience in clinical document management or equivalent experience preferred.
2. Demonstrates analytical and critical thinking skills.
3. Excellent oral and written communication skills; ability to facilitate cross-functional team meetings.
4. Demonstrates awareness of clinical documentation business procedures. Compliant to clinical documentation processes
?5. Experienced in using Microsoft PowerPoint and Excel &/or Document Management Systems preferred.
*CO/NYC candidates might not be considered
*Depending on experience
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.
1. Bachelor's degree or international equivalent preferred. Minimum 2 years relevant industry experience in clinical document management or equivalent experience preferred.
2. Demonstrates analytical and critical thinking skills.
3. Excellent oral and written communication skills; ability to facilitate cross-functional team meetings.
4. Demonstrates awareness of clinical documentation business procedures. Compliant to clinical documentation processes
?5. Experienced in using Microsoft PowerPoint and Excel &/or Document Management Systems preferred.
*CO/NYC candidates might not be considered
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