Senior Business Analyst (Clinical Operations, Study)

Our client, one of the biggest pharmaceutical companies based in Basel, is looking for a SENIOR BUSINESS ANALYST who has PROVEN EXPERIENCE in STUDY or CLINICAL OPERATIONS.

This is a long-term contracting role based in Basel and planned to start in June until end of 2019 with extension opportunities until June 2020!

Are you a Senior Business Analyst with excellent experience in collecting process/systems requirements from diverse stakeholders within regulatory area and currently looking for your next opportunities within one of the major innovative pharmaceutical company?

If so, please have a look at the opportunity we can offer you:

Project 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

TASKS:

- 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
- 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
- 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)

IDEAL PROFILE:

- 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.
- Empowering others and driving sponsorship
- Great communication skills (excellent English language skills)

NICE TO HAVES

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

Please note, we can only consider EU/CH candidates or those with a valid work permit for Switzerland.

Are you interested with this opportunity and would like to have more information?

Please get in touch with Florence Wespiser.

Please note that only shortlisted candidate will be contacted.