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CGI Technologies and Solutions, Inc. Clinical Lead/BA/SME in Wilmington, Delaware

Clinical Lead/BA/SME

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Clinical Lead/BA/SME

Category: Business Analysis (functional and technical)

City: Wilmington, Delaware, United States

Position ID: J0820-1801

Employment Type: Full Time

Meet our professionals

CGI: An employer of choice

Position Description:

Act as clinical BA on projects across the Emerging Accts group. Will support bus dev by authoring proposal content, presenting to customers, and supporting customer meetings. Will collaborate with the LS Ind Prac Clinical SMEs.

Your future duties and responsibilities:

• Authoring Business & Integration User Requirements (URS / Interface URS)

• Updating existing SOPs and/or conduct SOP Gap Assessments

• Drafting of project level communications / newsletters

• Support drafting test scripts & executing dry runs of clinical scripts for system testing and/or UAT prep

• Author business support models and/or transition planning for steady-state

Required qualifications to be successful in this role:

Strong knowledge of clinical operations business processes and the systems used to support those processes;

Experience working at multiple pharma or biotech firms in the clinical area, as FTE or consultant;

Good knowledge of clinical business/technical architecture, meaning knowledge of typical data flows and systems for managing trials, clinical data, operational data, TMF, CFR part 11 validation requirements, EDC, CRO roles;

Some knowledge of adjacent processes, i.e. pharmacovigilance (safety), biostats, regulatory/submissions

Experience in business and technology consulting in the clinical area;

Excellent communication skills, both written and oral;

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 .

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 . 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.