SSO Study Start-Up Manager

Job Description Summary

-Contributes, with appropriate oversight, to all aspects of global clinical trial(s) to deliver study outcomes within schedule, budget, quality/compliance and performance standards. May lead specific aspects of global clinical trial process. Contributes to operational excellence through process improvement and knowledge sharing.

Job Description

Major accountabilities:

• Manage all operational aspects of assigned clinical trials / projects -Accountable for quality & completeness of qualification & governance documentation -Provide mentorship/coaching -Identify training needs & prepare/develop adequate training materials -Ensures trial site selection, activation, enrolment, resource allocation, timelines & budget commitments are delivered per established trial objectives -Reporting of technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Key performance indicators:

• Timely, efficient and quality execution of trials and trial related activities within assigned clinical program(s) within budget, and in compliance with quality standards.
• Appropriate funding and resourcing for assigned clinical program(s).
• Adherence to Novartis policy and guidelines and external regulations.

Minimum Requirements:
Work Experience:

• Critical Negotiations.
• Financial Management.
• Collaborating across boundaries.
• Operations Management and Execution.

Skills:

• Budget Management.
• Clinical Trials.
• Negotiation Skills.
• People Management.
• Process Improvement.
• Project Management.
• Project Planning.
• Vendor Management.

Languages :

• English.
• German

Skills Desired

Budget Management, Clinical Trials, Negotiation Skills, Process Improvement, Project Planning, Vendor Management, Waterfall Model