Study Start-up Team Lead-contracts and Finance

*Role can be based in Madrid or Barcelona*
The SSO Study Start-Up Team Lead is accountable for the governance and oversight of a study start-up team in a standalone country or OPC (operating country). The SSO Study Start-Up Team Lead is supporting the country/OPC SSU strategy and prioritization in close collaboration with SSU/OPC Head and Country/OPC LT to deliver operational excellence of the GDD portfolio in compliance with Novartis processes, ICH/GCP and regulatory requirements.
The Start-Up Team Lead - Contracts and Finance will be responsible to set up the contract strategy within Start-Up Unit and, working in close collaboration with local Start-Up team and Sites/Institutions, will be responsible to ensure proper contract finalization within timelines.
Study Start-Up Strategy
- Supports Study & Site Operations 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
- Seeks and evaluates external knowledge and best practices to enhance overall operational excellence of country trial operations
- Supports country SSU strategy in close collaboration with SSU/OPC Head and Portfolio Head/Portfolio Team Lead(s)
- Responsible for timely start-up activities from country allocation until site Green Light (ready-to-initiate-sites)
- Ensures close collaboration with local IRBs/IECs and Health Authorities, as applicable

Allocation, initiation and conduct of trials
- Collaborates with Head Portfolio, SSO Portfolio Team Leads and global study team (Clinical Operations Program Head, Trial Lead) to ensure SSU timelines and deliverables are met according to country commitments
- Accountable for timelines, accuracy, and quality of TMF documents, including study start-up and ongoing TMF maintenance to ensure TMF inspection readiness
- Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
- Implements 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
- Resource management and reporting of Study Start-Up associates
- Ensures associates have the required level of skills to successfully set-up and execute studies with high quality and according to business objectives
- Manages and oversees productivity targets per defined objectives, and serves as an escalation point for Study Start-Up functions
- Interfaces with global trial execution organization through Global SSU managers for all portfolio deliverables.
- Partners with SSU CRAs to drive all trial level start up activities including essential document collection.

Key Performance Indicators:
1. Performance against study commitments at the country level (actual vs. planned patients), including set-up/delivery of trials per defined timelines and milestones (IRB/IEC & HA approval, RIS, SIV) and data quality requirements
2. Delivery of study milestones in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements
3. Timely submission and delivery of high-quality clinical trial documentation/data

**Commitment to Diversity & Inclusion**:

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

**Minimum requirements**

**Education**:

- A degree in scientific or health discipline required

Languages:

- Fluent in both written and spoken English
- Fluent in both written and spoken country language

Experience/Professional requirement:

- Minimum 5 years’ experience in clinical operations and planning
- Proven leadership capabilities and experience (with or without direct line management responsibilities).
- Understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring
- Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/national Health Authorities regulations and Novartis standards
- Experience in managing and negotiating clinical trial contracts with Sites/Institutions

Competencies:

- Strong capability in working in a global/country matrix environment
- Proven successful leadership of teams (with or without direct reports), preferably with experience in working with international teams

Skills & Knowledge:

- Strong interpersonal, negotiation and conflict resolution skills
- Communicates effectively in a local/global matrixed environment

**Division**

Global Drug Development

**Business Unit**

GCO GDD

**Country**

Spain

**Work Location**

Barcelona Gran Vía

**Company/Legal Entity**

Novartis Farmacéutica, S.A.

**Functional Area**

Research & Development

**Job Type**

Full Time