Business Analyst (GxP)

For our client in BASEL we are looking for a BUSINESS ANALYST WITH GXP EXPERIENCE for a 6-MONTHS project.

DURATION: 25/06/2018 TILL 31/12/2018 (EXTENSION PLANNED TILL THE END OF 2019)

LOCATION: BASEL/KAISERAUGST

WORKLOAD: 100%

The new Clinical Trial Regulation (CTR) is being implemented in the EU to replace the current Clinical Trial Directive (CTD). The Clinical Trial Regulation will improve the efficiency and effectiveness of study start up and management, to shorten the overall drug development timelines.

We are looking for a Senior Business Analyst to support the CTRi (Clinical Trial Regulation Implementation) Program. In this role, the Senior Business Analyst will report into Workstream 4 of the CTRi program and will support the Lead Business Solution Manager to gather requirements from multiple stakeholders (Business and IT) across the organisation in order to support the multiple systems solutions implementation for the TO-BE end to end process for CTRi.

SUMMARY OF RESPONSIBILITIES:
- Elicit and analyze detailed requirements for Planning and Tracking Solution (interim)
- Elicit and analyze detailed requirements as well participate in development of detailed "To-Be " process for Notifications
- Elicit and analyze detailed requirements as well participate in development of detailed "To-Be " process for Amendments (if needed)
- Participate and detail out the "To-Be Process" so as to be used by Solution Implementation teams
- Documentation all of the above
- Support in analysis of Metadata Management Tool requirements
- Participate in meetings, workshops and discussions

TASKS AND RESPONSIBILITIES:
. Accountable to Workstream 4 for eliciting requirements for multiple solutions to the overall program
. Requirements organization
. Simplifying requirements and validation
. Requirements management (including contradictory ones) and communication
. Requirements analysis
- Recommend solutions

MUST HAVES:
. 7+ years of experience in IT environment (in Regulatory domain highly preferred) with focus on business analysis and/or resolving customer's problems
. Knowledge of Business Analysis techniques and GxP experience
. Customer-focused project experience
. Proven experience with interacting effectively with colleagues at every level (eg Senior Management, customers, vendors, peers)
. Ability to gather, document and analyze requirements
. Ability to anticipate potential problems, determine and implement solutions, teamwork and organizational skills
. Translate high-level requirements into high-level solutions
. Ability to influence decision making through analysis
. Very good communication and written skills in English
. Openness and flexibility to work in a different time zone
. Soft skills: Problem solving & proactive attitude, team player and self-organized, can-do attitude and analytical mind

NICE TO HAVES:
+++ Knowledge of pharmaceutical industry (ie medical terminology, regulatory requirements)
++ Awareness of the EU Clinical Trial Regulation

For further details please contact Beata Arciszewska:
(see below)