CGI Technologies and Solutions, Inc. Medical Business Analyst in Waterville, Maine
Medical Business Analyst
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Medical Business Analyst
Category: Business Analysis (functional and technical)
City: Waterville, Maine, United States
Position ID: J0918-1659
Employment Type: Full Time
CGI is seeking a business analyst with a health care and/or Life Sciences-related background. This position will be based out of our Waterville, Maine Delivery Center.
Your future duties and responsibilities:
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.
The TMF Analyst will ensure the clinical trial documentation is consistent with agreements and applicable SOPs, ICH GCP.
Scan supporting documentation, including identification defining the original record and reconciling copies, analysis of data elements, records management, indexing and scanning.
Respond to audit search requests
Support records management, retention and litigation requests.
Reconciling and remediating paper records
Collaborates with client study teams regarding TMF review and management.
Works with Lead TMF Analyst and TMF Compliance Specialist to locate and identify areas yielding highest efficiency.
Address requests in a timely and efficient manner.
Understand all technical aspects of applicable TMF system and associated tools, including work instructions, metrics timelines, and relevant processes.
Works with users to identify and manage study expected document lists.
Responsible for supporting TMF business user questions.
Required qualifications to be successful in this role:
• Prior experience using computerized information systems, including demonstrated proficiency with word processing, spreadsheet, database and presentation software
• Read, write, and speak fluent English
• Undergraduate degree in progress or its international equivalent in clinical, science, or health related field from an accredited institution or a licensed healthcare professional
• Close attention to detail, excellent follow-through skills and proven client engagement experience
DESIRED QUALIFICATIONS / NON-ESSENTIAL SKILLS REQUIRED
• 2 years of related experience preferred
• 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
Minimum Education Required: Associates Degree
What you can expect from us:
Build your career with us.
It is an extraordinary time to be in business. As digital transformation continues to accelerate, CGI is at the center of this change—supporting our clients’ digital journeys and offering our professionals exciting career opportunities.
At CGI, our success comes from the talent and commitment of our professionals. As one team, we share the challenges and rewards that come from growing our company, which reinforces our culture of ownership. All of our professionals benefit from the value we collectively create.
Be part of building one of the largest independent technology and business services firms in the world.
Learn more about CGI at www.cgi.com .
No unsolicited agency referrals please.
CGI is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to their race, ethnicity, ancestry, color, sex, religion, creed, age, national origin, citizenship status, disability, medical condition, military and veteran status, marital status, sexual orientation or perceived sexual orientation, gender, gender identity, and gender expression, familial status, political affiliation, genetic information, or any other legally protected status or characteristics.
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