Medical Business Analyst

Waterville, Maine

Contact Details

Job Description

Responsibilities include providing business processing support for clinical trials and management of electronic Trial Master File (TMF) data and records. The TMF is a pharmaceutical record that contains all the essential documents relating to a clinical trial. Working as part of a team executive business process activities in support of clinical trials, and ensuring content according to the established processes. 

Responsible for working with various teams in supporting the management of TMF documents and maintaining inspection readiness and submission readiness within the applicable TMF system.

1. The TMF Analyst will ensure the clinical trial documentation is consistent with agreements and applicable SOPs, ICH GCP. 

2. Scan supporting documentation, including identification defining the original record and reconciling copies, analysis of data elements, records management, indexing, and scanning.

3. Respond to audit search requests

4. Support records management, retention and litigation requests.

5. Reconciling and remediating paper records

6. Collaborates with client study teams regarding TMF review and management. 

7. Works with Lead TMF Analyst and TMF Compliance Specialist to locate and identify areas yielding highest efficiency.

8. Address requests in a timely and efficient manner. 

9. Understand all technical aspects of applicable TMF system and associated tools, including work instructions, metrics timelines, and relevant processes. 

10. Supports Audits/Inspections.

11. Works with users to identify and manage study expected document lists.

12. Responsible for supporting TMF business user questions.

Required qualifications to be successful in this role:.

2 years of experience in clinical research or clinical trials preferred.

Consideration extended to candidates with experience in study coordination, nursing, health records management, or clinical trial administration.

Clinical trials support or pharmaceutical industry experience preferred. 

Knowledge of the complete clinical trial conduct process 

Knowledge of electronic document management applications (e.g., Documentum, SharePoint, Livelink) preferred

Knowledge of ICH and local regulatory authority drug research and development regulations preferred.

Knowledge of Trial Master File industry accepted standards, such as the DIA TMF Reference Model

Analytical / logical, with superior attention to detail and an inclination to spot patterns and outliers

Be able to demonstrate a flexible, proactive, diligent and self-motivated approach to work

Experience using electronic document management system

 

Skills

  • Business Analysis