Sr. Consultant - Life Science Clinical eTMF

Category: Business Consulting, Strategy and Digital Transformation
City: Plymouth Meeting, Pennsylvania, United States
Position ID: J1019-1681
Employment Type: Full Time
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Position Description

POSITION DESCRIPTION

As the Senior Consultant, Consulting Services, you will have responsibility to manage and lead R&D consulting projects. This role will contribute positively to developing business relationships with clients and internal (client) stakeholder members. As a leading expert in (electronic) Trial Master File (eTMF), you will be an integratal part of the Life Sciences consulting team focused on providing strategic guidance and supporting successful implementation programs.

FUTURE DUTIES AND RESPONSIBILITIES

The Senior Consultant, Consulting Services will:

- Be responsible for delivering the business sprocess transformation and change management aspects of large scale programs.

- Supporting implementation of eTMF systems and supporting business processes

- Serve as a key subject matter expert in eTMF and other aspects of clinical operations

- Will need to develop and maintain strong relationships with existing clients and become attuned to potential business within the client.

REQUIRED QUALIFICATIONS TO BE SUCCESSFUL IN THIS ROLE

• 10+ years of minimum Clinical operations, with a focus on eTMF, Veeva Clinical platforms and/or other clinical operation platforms. Consulting experience a plus.

• Experience defining future state business processes within Clinical Operations

• Specific expertise in Trial Master File, including business processes, systems implementation, analysis

• Strategy and business management

• Delivery experience

• A keen, flexible and aggressive intellect; superior conceptual thinking as well as analytical and problem solving skills

• Strong communication skills, both verbal and written, at all levels

• Proven record of creating and maintaining business partnerships and relationships

• Strong decision making, judgment and analytical skills

• Demonstrated ability to effectively collaborate with cross-functional virtual teams

• Knowledge of Regulatory guidelines such as, US FDA, EU, ICH, GCP, GMP and ISO.

• Experience in gathering and documenting requirements, Business Process Analysis, Change Management Concepts, Current/Future State Analysis

Skills

  • Change Management
  • Communication (Oral/Written)
  • Business Architecture

What you can expect from us

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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 US_Employment_Compliance@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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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 US_Employment_Compliance@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.

We make it easy to translate military experience and skills! Click here to be directed to our site that is dedicated to veterans and transitioning service members.