Business Analyst in Data Standarization

For our client in BASEL we are looking for a SENIOR BUSINESS ANALYST in Data Standarization for a 19-MONTH project.

DURATION: 01/06/2018 TILL 31/12/2019

WORKLOAD: 100%

LOCATION: BASEL

BACKGROUND:

. CTRi Project was established to serve two business needs: 
The need to be compliant with the new Clinical Trial Regulation (CTR) being implemented to replace the current Clinical Trial Directive (CTD) 
The need to improve the efficiency and effectiveness of study start up and management and shorten the overall drug development timelines
. MODS Standardization efforts support CTRi in meeting both those needs

OBJECTIVES:
. MODS will develop data standards to create transparency and consistency for the functions writing and reading data for trustworthy regulatory reporting
. Support adoption of standards for Study in MDMS (master data management system) and facilitate adoption in other systems as the data design is finalized
. Enable re-use of data; example for Trial submissions also outside of the CTR context
. Create clear data accountability framework for submission data paving the way to support a clean stack of study protocol information which not only reduces the time for trial submissions outside of EU but also contributes to faster high quality, consistent study data submission
. Enable re-use of data thus reducing and/or eliminating the need for redundant data entry in systems and processes

TASKS & RESPONSIBILITIES:

. Data assessment for 279 data fields in scope for Clinical Trial Application submission resulting in creation and execution of a detailed plan to standardize a selected set of data objects based on assessment within the scope of MODS
. Facilitation of standards adoption in source of truth (System and/or Document) & Processes
. Source to Target Mapping & calculations as needed
. Identify opportunities to re-use data & support implementation to eliminate manual entry or redundancy
. Identify opportunities and designate system of record for adoption in MMT & Submission process
. Establish Data Accountability Matrix and a governance process to ensure monitoring of data after standards are adopted in systems, processes & reports
. Manage Scope, Schedule and inter work stream (ws1-4) dependencies to ensure on time delivery of Study Standards
. Promote the Data Citizenship Program developed by Pharma Data Governance team through the CTRi change management Team as an additional benefit of the engagement
. Impact Analysis to systems & processes resulting from standards development
. Impact Analysis to processes and roles affected by the data standards of 279 objects in scope
. Leveraging work from other OTI-MODS DGO and IDMP: DSDG engagements (eg The MODS DGO is refining the MODS Process. This will be used by the CTRi team at no extra cost or effort)
. Leverage from current CTA CRUD analysis and (EutraCT) data attributes
. Identify synergies and partnership opportunities between Study Domain Portfolio and CTRi release plan (example: merging standards needs for CTRi project with other efforts (eg. Primary Endpoints for IPP & CTRi can be batched into one standards package)

MUST HAVES:

. 7+ years of experience as Senior BA with domain knowledge (Clinical, Study)
. 7+ years of relevant experience in a multinational company
. 7+ years of experience in Study or Clinical Operations or Regulatory Experience is highly required
. Excellent communication skills demonstrated by communicating with business stakeholders and technical development team (writing change requests & user requirement specifications)
. Experience collecting process/system requirements from diverse stakeholders, aligning them to a final design
. Experience executing of Process/Systems improvements and understand their impacts (3 pillars: People, Process & Technology)
. Knowledge of how data quality impacts the performance of a process/system and how you addressed the gaps/issues. Who was involved and why?
. Industry expertise versus core BSA (business systems analysis) capability. How does the person handle when they are not the expert on the topic and brought stakeholders together to express their knowledge and show how you captured it.
. Great communication skills (excellent English language skills)

Nice to Haves: 

. Data Stewardship and curation is a plus 
. Advance excel is preferred 
. SQL is preferred

For further details please contact Beata Arciszewska.