Start UP Manager

Responsibilities:
1.Coordination of necessary activities to generate European documents needed for initial submission of study package in collaboration with other functional teams.
2.To be involved in all study related planning meetings
3.Preparation of EU documents for submission of Substantial Amendments and Declaration of End of Trial Forms in close collaboration with the project team.
4.Communicating of all information and issues, liaising with country offices , Clinical Managers, and CRO's (for outsourced studies) to ensure that study start up activities are in compliance with study timelines, local regulatory guidelines and regulations.
5.Participation in cross functional teams, to continuously improve study start-up and study conduct processes through sharing of best practices and issue identification/resolution.

Requirements:

*Experience in site management or equivalent in the pharmaceutical industry.
*Demonstrated success in using oral and written communication and presentation skills to influence, inform or guide others.
*Experience in effective implementation of clinical plans/documents and document preparation.
*Previous experience working in an international team environment within a matrix organization.
*Experience in planning and coordination of study initiation.

This role is for 6 months fixed term contract. Local candidates are only considered at present.