Your responsibilities include but are not limited to:

Study Start-Up Strategy

• Supporting Country Leadership Team to identify innovative practices to optimize country operations and operational excellence, especially in terms of study start-up activities to increase performance, productivity, and business impact
• Seeking and evaluating external knowledge and best practices to enhance overall operational excellence of country trial operations
• Responsibility for timely start-up activities from country allocation until site activation
• Ensuring close collaboration with sites/Institutions, as applicable

Allocation, initiation and conduct of trials

• Collaborating with Portfolio team and global team to ensure SSU timelines and deliverables are met according to country commitments
• Accountability for timelines, accuracy, and quality of TMF documents, including study start-up and ongoing TMF maintenance to ensure TMF inspection readiness
• Ensuring adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
• Implementing innovative and efficient processes which are in line with Novartis strategy

People and resource management

• Hiring, training, development, and retention of Study Start-Up associates
• Resourcing management and reporting of Study Start-Up associates
• Ensuring associates have the required level of skills to successfully set-up and execute studies with high quality and according to business objectives
• Managing and oversees productivity targets per defined objectives, and serves as an escalation point for Study Start-Up functions

Essential Requirements:

• A degree in scientific or health discipline required

• Fluent English and Spanish (both written and spoken)

• Minimum 5 years’ experience in clinical operations and planning

• Proven leadership capabilities and experience (with or without direct line management responsibilities).

• Deep understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring

• Thorough knowledge of the international aspects of drug development process, including international standards (GCP/ICH), health authorities (FDA/EMA), local/national Health Authorities regulations and Novartis standards

• Experience on managing and negotiating clinical trial agreements (Sponsor, Third party or Site institution experience is acceptable)

Desirable Requirements:

• Knowledge on Spanish and Portuguese legal framework will be 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. http://www.novartis.com/careers/benefits-rewards

Other Spanish standard benefits are Company Pension Plan; Life and Accidental Insurance; Meals, Allowance or Canteen in the office; Flexible working hours.

Commitment to Diversity and Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

Accessibility and accommodation:

Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message.