Global Project Manager (Non Interventional Study)

Major Responsibilities

• Project management of global NIS with up to 20,000 and more patients for strategically important products worldwide.
• Management and coordination of study teams involved in the global/regional and local functions (Integrated Global Analysis, Regulatory Affairs, Pharmacovigilance, Health Economics, NIS Data Management).
• Coordination of internal and external functions partners (e.g. CROs).
• Preparation of the selection process for CROs by generation of Service Descriptions and significant contributions for decision making in selection meetings.
• Coordinating and preparation of all relevant documents and studies systems.
• Creation of Milestones/RFPs budget planning and monitoring of project budgets.
• Coordination of evaluation, documentation and archiving of study results and communication internally and externally.
• Implementation of international standards and regulatory requirements (IFPMA, EFPIA, FDA, VFA, FSA, BfArM) including Trial Posting.

Requirement

• Scientific university degree or equivalent qualification with relevant work experience.
• Fluent English (spoken and written).
• > = 3 years experiences in global project management of NIS.
• Computer literacy skills over and above normal users.
• Strong communication skills.
• Joined-up thinking.
• Perseverance and resilience.