SSO Study Start-Up Manager

-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.

About the Role

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.
• Ensure trial site selection, activation, enrolment, resource allocation, timelines & budget commitments are delivered per established trial objectives.
• Report technical complaints / adverse events / special case scenarios related to Novartis products within 24 hours of receipt.
• Distribute 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.
• Critical Negotiations.
• Operations Management and Execution.

Skills:

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

Languages :

• German

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Location: Germany, Nuremberg (Non-Sales Force) (Novartis Pharma GmbH)

Company / Legal Entity: DE14 (FCRS = DE014) Novartis Pharma GmbH

Functional Area: Research & Development

Job Type: Full time

Employment Type: Temporary (Fixed Term)

Shift Work: No

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve. Hiring decisions are only based on the qualification for the position, regardless of gender, ethnicity, religion, sexual orientation, age and disability.