🚀 Clinical Trial Manager

Overview

Clinical trials Study Start-up Team Lead (m/f/d) – Contracts and Finance. Location: Iberia (Spain & Portugal). Reports to the Study Start-up Country Head and collaborates with the study start-up team and country leadership.

Role objective: govern and oversee the study start-up team responsible for contracts and finance activities, set strategy and priorities to achieve quick site activation and timely payments, while ensuring operational excellence and compliance with Novartis processes, ICH/GCP and regulatory requirements.

Responsibilities Study Start-Up Strategy

• Support the Country Leadership Team to identify innovative practices to optimize country operations and operational excellence in study start-up activities, aiming to improve performance, productivity, and business impact.
• Seek and evaluate external knowledge and best practices to enhance overall operational excellence of country trial operations.
• Be accountable for timely start-up activities from country allocation until site activation.
• Ensure close collaboration with sites/institutions, as applicable.

Allocation, initiation and conduct of trials

• Collaborate with Portfolio and global teams to meet SSU timelines and deliverables according to country commitments.
• Be accountable for timelines, accuracy, and quality of TMF documents, including study start-up and ongoing TMF maintenance to ensure TMF inspection readiness.
• Ensure adherence to financial standards, applicable legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.
• Implement innovative and efficient processes aligned with Novartis strategy.

People and Resource Management

• Hire, train, develop, and retain Study Start-Up associates.
• Manage resourcing and report on Study Start-Up associates.
• Ensure associates have the required skills to set up and execute studies with high quality and according to business objectives.
• Manage productivity targets and serve as an escalation point for Study Start-Up functions.

Essential Requirements

• A degree in a scientific or health discipline.
• Fluent in English and Spanish (written and spoken).
• Minimum 5 years’ experience in clinical operations and planning.
• Proven leadership capabilities and experience (with or without direct line management).
• Deep understanding of all aspects of clinical drug development with emphasis on trial set-up, execution, and monitoring.
• Thorough knowledge of international drug development standards (GCP/ICH), health authorities (FDA/EMA), local/national regulations and Novartis standards.
• Experience in managing and negotiating clinical trial agreements (sponsor, third party, or site institution experience acceptable).

Desirable Requirements

• Knowledge of Spanish and Portuguese legal frameworks is highly valued.
• Language: knowledge of Portuguese.

You Will Receive

You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook at the following link: Other Spanish standard benefits include Company Pension Plan;

Life and Accidental Insurance;

Meals, Allowance or Canteen;

Flexible working hours.

Commitment to Diversity and Inclusion: Novartis is committed to an outstanding, inclusive work environment with diverse teams representative of the patients and communities we serve.

Accessibility and Accommodation

Novartis provides reasonable accommodation to all individuals. If you need accommodation for any part of the recruitment process due to a medical condition or disability, please email with the nature of your request and your contact information, including the job requisition number.

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Seniority level: Mid-Senior level

Employment type: Full-time

Job function: Health Care Provider

Industries: Pharmaceutical Manufacturing

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