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Data Design Senior Analyst/ Senior IT Project Manager/ Senior UAT & QC Specialist ShortList

Noor Khanum ( 55 )

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General Information

  • Gender Female
  • Mobile Number 0565618579
  • Address Villa 108, Al Imam Muslim Street, Al Dafrah, Al Manaseer
  • Objective Seeking a position to utilize my skills and abilities in the industry that offers professional growth while being resourceful, innovative and flexible to industry.
  • Vacancy Category  ITSEO Analyst
  • Total Years of Experience 6
  • Expected Job Level Mid-level
  • Employement Type Full Time
  • Visa Status Visit

 IT Project Management experience in a clinical supply chain management environment prior to clinical trials.
 Manages specific projects and activities related to that project within given constraints of scope, schedule, budget and quality through the duration of the project.
 Develop end to end project plan in alignment with all key stakeholders (internal, vendors, clients, etc.)
 Coordinate communication between teams, managing effective relationships, and ensuring effective execution of agreed contracts with scope of work and to Ensure resource availability,
allocation and tracking.
 Provide coordination for kick-off meetings for projects and ensure that all relevant stakeholders are aware of the tasks required of them.
 Conducts periodic reviews to ensure the project is on track and conducts post-project reviews.
 Ensures all project documentation is kept up to date and communicated to the relevant stakeholders on a timely basis.
 Utilizes relevant project management tools systems, and applications such as Project checklist, MIVRS Database to extract Grant charts/ Timelines Graphs charts.
 Develop, maintain, and publish projects KPIs, status reports, and dashboards that effectively and reliably track project quality, delivery, and predictability for various stakeholders and leadership.
 Perform IVRS testing and Quality control on day-to-day activities when issues are escalated.
 Good Knowledge on GCP, GDP, CAPA, CPI, KPI, SWI, SOP, SLA, RCA, UAT, QC and QA.
 Experience in handling projects of Therapeutic Area such as Oncology, Cardiovascular, Vaccine, Neuro and more.
 Manage defects and assign them to the developers for fixes. Evaluate the impact of a bug on the system, prioritizing them for new build/fix. Retest defects; pass on to the stakeholders for
a recheck of UAT.
 Expertise in analysing business user requirements and extensive knowledge in gathering and understanding BRD (Business Requirements Document), SRS (Software Requirement Specifications) and Use cases.
 Basic knowledge on Pharmacovigilance, Artificial Intelligence.
 Experience in conducting Internal Audit and External Audit/ Inspection as per FDA regulations using Audit methodology and development of robust inspection readiness.
 Experience in handling Compliance activities.                         Leading and conducting training sessions for technical team on process as per SOP’s.                                                                        Experience in Business Excellence/ Business Analyst – Excellent in preparing metrics/reports using tools such as 3*3 scorecard, FMEA (Failure Mode and Effects Analysis), Effort Estimation report for the team.
 Experience in working in a regulated, documented environment.
 Participate in process improvement initiatives, standard development and maintenance.
 Actively participate and expedite the SDLC across design, build, testing and Go Live in
coordination with relevant teams with Quality.
 Adept strategist and transforms strategic plans into workable solutions and continuously
benchmarks to ensure performance improvement on key process indicators and organizational
objectives.
 Able to assume and work autonomously in a professional manner.

Work Experience

May 2015 – Feb 2020
Accenture Solutions Pvt. Ltd, Bangalore, India.Data Design Senior Analyst/ Senior UAT & QC Specialist/ Senior IT Project Manager

 Provide comprehensive project management to ensure the successful completion of assigned clinical research programs and projects. Proficient in protocols for defining and validating protocols for clinical studies and handling prior clinical trials responsibilities throughout the data management life cycle. Partners with stakeholders to define instances where data exchange is needed Collaborates with stakeholders to determine the In-scope items. Oversees initial and amendments testing to ensure projects are timely, efficient and bug-free. Provide guidance to the client project team and vendor of any mismatch in the requirements. Maintain project specific issue and risk log Document issues and facilitate investigation into root cause, corrective action and, as applicable, preventative action. To Ensure resource availability, allocation and Tracking project specific risks and remediation’s. Facilitating kick-off meetings with clients and Vendors. Provides support for execution of IRT and PRO UAT development process from UAT planning to system Go-live, ongoing system change control and system closed out. Reviews and provides approval of required IVRS and PRO trial specific documents. Manage UAT timelines and liaise with the external vendor and the Clinical team to develop business scenarios for testing purpose. Co-ordinate and monitor the execution of UAT scripts and development and compilation of all other required documents in GXP environment according to FDA regulations and SOP’s. Develops UAT Plans, Requirement Trace Matrix, Risk Assessments, Gap Analysis, Test Scripts, Data Set-up requests, Test Summary Reports, developing and managing the regression test suite in a GxP Environment according to FDA regulations. Facilitating weekly or biweekly client meetings to review project status or any system changes needed.
 Trouble shooting system issues and working with technical team to drive updated build into production. Experience in project managing and monitoring multi-centre clinical research studies Understanding of the local and global regulatory clinical research requirements (ICH and GCP). Perform quality control reviews and approvals of the validation strategy and deliverables to sustain compliance. Develop deliverables for PDAMNG Next Generation and Umbrella studies. Perform Essential Document Review (Inspection Readiness) for Internal and Onshore Client team according to FDA regulations.


Summary of Skills

 Excellent communication skills.  High level computing skills (Word, Excel, Access, PowerPoint) and typing at good speed.  Good organizational and time management skills.  Good Project Management and Presentation skills.  Excellent interpersonal and leadership skills  Analytical skills.  Report writing skills.  Ability to handle multiple projects with rapidly changing priorities and deadlines.  Self-motivated with an abundance of energy and drive. Organized and methodical approach.
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