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Advanced Business Analyst - EDC System - India  

Novo Nordisk (company)


Posted on : 20 March 2017

Project Description

Job Description
  •  Corporate IT is the unit responsible for several global IT systems at our company including the operation, maintenance, support and development of these systems. 
  • The systems are used on a global scale by all areas of the business from R&D to Sales and are critical to the execution of key business processes such as development, manufacturing, sales, finance, etc.
  • This position holder plays the role of Advanced Business Analyst who will be responsible for the Validation, Compliance and Release management of EDC system.
  • The holder of the position will be responsible in managing computer system validation (CSV) activities for GxP critical IT system, including all the system documentation creation, review/approval for the CSV deliverables like user requirements, system specifications, Validation Plan, Qualification Plans, Standard Operating Procedures (SOPs), Functional Risk assessment, protocols authoring/reviewing/approving, Traceability matrix, Design Specs, and validation summary reports, also practice ITIL processes for user support.

Primary responsibility of this position holder will be as below:
  •  Managing changes & releases for EDC and EDC Standard Reports which includes planning and execution of release strategy
  •  Primarily responsible for validation & compliance management of the EDC system and Standard Reports
  •  Responsible for setup & validation of EDC interfaces.
  •  Supporting Periodic reviews i.e System Annual Reports
  •  Work closely with the project team members or team member in Denmark, and the Quality Assurance function of the organization

Electronic Data Capture (EDC) 
  • It is a system, which replaces manual entry of data in clinical trials with a more effective and faster electronic entry. 
  • EDC improves data quality, increases data availability and shortens the interval from last patient last visit to Data Base Lock. 
  •  EDC replaces manual entry of CRF data in clinical trials with investigator site entered electronic data, submitted via the internet.
  • This is a SaaS system / cloud solution

Main job tasks listed below:
  •  Managing changes and new releases end to end on EDC system & standard reports with GXP compliance. 
  • This includes collecting requirements from the business (LoB), performing necessary qualification, reporting to ensure successful deployment of the change /release. 
  • Participate in new releases, defect management, test coordination / validation, quality risk assessment, Design review etc.
  •  Manages computer system validation work, assuring the thoroughness of validation planning and making appropriate progress towards completion of validation work.
  •  Validation responsible for EDC system & Standard Reports which includes compliance management, handling of remarks & Non Conformities, for both EDC & Standard Reports.
  •  Validation & set up of interface from EDC system for each new clinical trials including customization of interfaces in certain cases. (EDC-IMPACT)
  •  Interface Co-ordination of all systems in R&D Solutions
  •  Participate in Annual Periodic reviews (User review report, Configuration review report, IT Periodic System Evaluation)
  • To ensure validated state of the IT System according to company  QMS and to work closely with QA to willful the overall quality assurance responsibility.
  •  Participate in system operation and maintenance in IT System Management.
  •  Perform Incident Support for user reported issues whenever needed.
  •  Support System Manager on the system management activities as and when required.
  •  Ensuring the quality and acceptance of all validation deliverables before the approval to Go-live during Release closing window.
  •  Handling Change requests in the production environment to comply with the Change Management work instruction.
  •  Participate in new Releases, Defect Management, Test coordination / Validation, Quality Risk Assessment, Design Review etc.
  •  Authoring, Review & sign off for the Validation deliverables
  •  Overall responsible for handling Remarks and NC’s (Non-conformance reports).
  •  Communicate and involve relevant stakeholders -alignment with LoB stakeholders, primarily System managers, ITQAs/LoB QAs, System Owners, Project Owners.
  •  Excellence in business and system understanding
  •  Demonstrate pro-activeness and ownership
  •  Manage own time planning and timely deliverables
  •  Communicate and involve relevant stakeholders
  •  Enhancing good team spirit and high degree of knowledge sharing

MSC, MBA, BA or similar graduate degree in relevant field (Software Engineering, Economics, Computer Science, Business Administration)

  •  8+ years of experience with IT
  •  4+ years of relevant experiences in QC Role/ CSV Role
  •  3+ years of pharmaceutical industry experience
  •  Proven ability to perform validations of critical IT System (Mandatory)
  •  Exposure to ITIL concepts (Prefered)

Personal skills:
  •  Good interpersonal skills
  •  Ability to collaborate and communicate with external parties, primarily users.
  •  Ability to represent our company in relations with users and external stakeholders
  •  Excellent communication skills written and orally in English
  •  Large degree of flexibility and the ability to work under strong time pressure
  •  Logical reasoning and analytical skills
  •  Highly proactive and able to take initiative
  •  Integrity and accountability
  •  Positive attitude and confident, highly focused with a quality mind-set and commitment.
  •  ITIL certification (preferable not mandatory)