Clinical trials Study Start-up Team Lead (m/f/d) – Contracts and Finance

Job title:

Clinical trials Study Start-up Team Lead (m/f/d) – Contracts and Finance

Company:

Novartis

Job description

Job Description Summary Internal Job Title: SSO Study Start-Up Team LeadAbout the Role:As Study Start-up Team Lead, you will be responsible for the governance and oversight of the study start-up team managing contracts and finance related activities in Iberia (Spain & Portugal). You will be responsible for setting up the right strategy and prioritization to achieve quick site activation and execution of payments through the course of the trials, while ensuring operational excellence and in compliance with Novartis processes, ICH/GCP and regulatory requirements.This role reports directly into the Study Start-up Country Head and will work hand in hand with the study start-up team and Country leadership team.#LI-HybridJob DescriptionYour responsibilities include but are not limited to:Study Start-Up StrategySupporting 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 impactSeeking and evaluating external knowledge and best practices to enhance overall operational excellence of country trial operationsResponsibility for timely start-up activities from country allocation until site activationEnsuring close collaboration with sites/Institutions, as applicableAllocation, initiation and conduct of trialsCollaborating with Portfolio team and global team to ensure SSU timelines and deliverables are met according to country commitmentsAccountability for timelines, accuracy, and quality of TMF documents, including study start-up and ongoing TMF maintenance to ensure TMF inspection readinessEnsuring adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirementsImplementing innovative and efficient processes which are in line with Novartis strategyPeople and resource managementHiring, training, development, and retention of Study Start-Up associatesResourcing management and reporting of Study Start-Up associatesEnsuring associates have the required level of skills to successfully set-up and execute studies with high quality and according to business objectivesManaging and oversees productivity targets per defined objectives, and serves as an escalation point for Study Start-Up functionsEssential 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.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 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.Skills Desired Budget Management, Clinical Trials, Negotiation Skills, People Management, Process Improvement, Project Planning, Vendor Management

Expected salary

Location

Barcelona

Job date

Wed, 27 Aug 2025 06:06:56 GMT

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