Advanced Business Analyst - EDC System - India
- 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)
- 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)