Sr. Business Systems Analyst

Waterville, ME, USA

Contact Details

  • Company: CGI - New England
  • Contact Name: Laura Cole
  • Contact Email:
  • Career Website: https://cgi.njoyn.com/cgi/xweb/XWeb.asp?tbtoken=ZV9RRxgXCBxwFnMHMFJSCFo6dhFEcCNUe0hZJSkEE2NaKkZpKzISAWpzcAkbVhRSSXEqWA%3D%3D&chk=dFlbQBJe&clid=21001&Page=JobDetails&Jobid=J0119-0630&BRID=660748&lang=1
  • Contact Phone: 207-660-4415CGI is seeking a Sr. Business Systems Analyst with a health care and/or Life Sciences-related background. This position will be part of our growing electronic Trial Master File (eTMF) service and is based out of our Waterville, Maine Delivery Center . Your future duties and responsibilities: • The eTMF Analyst will consistently ensure that TMF is inspection ready and in alignment with the study agreed strategy and applicable milestones. • The TMF Analyst will ensure the clinical trial documentation is consistent with trial master file agreements and applicable SOPs, ICH GCP. • Provision of project management expertise to Study Accountable Person (SAP) and their study team members globally as needed (e.g. instream quality check of trial master file data, drafting and preparation of documents etc.) to support their study deliverable targets, to agreed quality and data integrity standards. • Serve as point of contact for the study teams for TMF matters and liaise with TMF Subject Matter Experts (SMEs) and process owners to help their understanding of requirements and associated solutions to ensure trial master files are inspection ready at all times. • Conducting analysis and identification of business problems/opportunities that may arise and support the implementation of high quality solutions. • Address requests in a timely and efficient manner. • Understand all technical aspects of applicable TMF system and associated tools. • Liaise with clients, performing as part of the cross-functional team. • The TMF Analysts will be required to ensure that the documents are filed to meet the required timelines and the Analyst would ensure there is no deviation from the plan and follow up appropriately. • The TMF Analyst would act as the expert and point of contact for any audit and inspections and assist with the development of correction action plans, if related to any findings. • The TMF Analyst will monitor and identify trends for a study they support. • The TMF Analyst will drive the TMF completeness metrics and track performance.- Required qualifications to be successful in this role: • Bachelor Degree or equivalent experience working in clinical research, clinical operations • Knowledge and experience of using clinical trial master file (TMF) systems (paper or electronic) and associated business processes • Knowledge of Trial Master File industry accepted standards, such as the DIA TMF Reference Model • Knowledge of electronic document management applications (e.g., Veeva, Documentum, SharePoint, Livelink) • Excellent working knowledge of International Conference on Harmonization/ Good Clinical Practice (ICH/GCP) regulations for sponsor study records • Excellent interpersonal skills, including the ability to establish and maintain effective working relationships with customers, peers and stakeholders • Proven record of being customer driven and providing effective consultation and training Self-starter, able to work independently, as well in matrix team environment DESIRED QUALIFICATIONS • 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

Job Description

CGI is seeking a Sr. Business Systems Analyst with a health care and/or Life Sciences-related background. This position will be part of our growing electronic Trial Master File (eTMF) service and is based out of our Waterville, Maine Delivery Center .

Your future duties and responsibilities:

• The eTMF Analyst will consistently ensure that TMF is inspection ready and in alignment with the study agreed strategy and applicable milestones.

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

• Provision of project management expertise to Study Accountable Person (SAP) and their study team members globally as needed (e.g. instream quality check of trial master file data, drafting and preparation of documents etc.) to support their study deliverable targets, to agreed quality and data integrity standards.

• Serve as point of contact for the study teams for TMF matters and liaise with TMF Subject Matter Experts (SMEs) and process owners to help their understanding of requirements and associated solutions to ensure trial master files are inspection ready at all times.

• Conducting analysis and identification of business problems/opportunities that may arise and support the implementation of high quality solutions.

• Address requests in a timely and efficient manner.

• Understand all technical aspects of applicable TMF system and associated tools.

• Liaise with clients, performing as part of the cross-functional team.

• The TMF Analysts will be required to ensure that the documents are filed to meet the required timelines and the Analyst would ensure there is no deviation from the plan and follow up appropriately.

• The TMF Analyst would act as the expert and point of contact for any audit and inspections and assist with the development of correction action plans, if related to any findings.

• The TMF Analyst will monitor and identify trends for a study they support.

• The TMF Analyst will drive the TMF completeness metrics and track performance.-

Required qualifications to be successful in this role:

• Bachelor Degree or equivalent experience working in clinical research, clinical operations

• Knowledge and experience of using clinical trial master file (TMF) systems (paper or electronic) and associated business processes

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

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

• Excellent working knowledge of International Conference on Harmonization/ Good Clinical Practice (ICH/GCP) regulations for sponsor study records

• Excellent interpersonal skills, including the ability to establish and maintain effective working relationships with customers, peers and stakeholders

• Proven record of being customer driven and providing effective consultation and training

Self-starter, able to work independently, as well in matrix team environment




DESIRED QUALIFICATIONS

• 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