Clinical Trials Study Start-up Team Lead

**Summary**:
Internal Job Title: SSO Study Start-Up Team Lead

About 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-Hybrid

**About the Role**:
**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**:
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**:
Division

Development

Business Unit

Innovative Medicines

Location

Spain

Site

Barcelona Gran Vía

Company / Legal Entity

ES06 (FCRS = ES006) Novartis Farmacéutica, S.A.

Alternative Location 1

Madrid Delegación, Spain

Functional Area

Research & Development

Job Type

Full time

Employment Type

Regular

Shift Work

No

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