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

Position Description:

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.

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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.

  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:

• 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.

CGI provides reasonable accommodations to qualified individuals with disabilities. If you need an accommodation to apply for a job in the U.S., please email the CGI U.S. Employment Compliance mailbox at USEmploymentCompliance@cgi.com . You will need to reference the requisition number of the position in which you are interested. Your message will be routed to the appropriate recruiter who will assist you. Please note, this email address is only to be used for those individuals who need an accommodation to apply for a job. Emails for any other reason or those that do not include a requisition number will not be returned .

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All CGI offers of employment in the U.S. are contingent upon the ability to successfully complete a background investigation. Background investigation components can vary dependent upon specific assignment and/or level of US government security clearance held.

CGI will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with CGI’s legal duty to furnish information.