Sso Contracting Specialist

2 settimane fa

Milano, Italia Novartis A tempo pieno

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO (Global Clinical Operations) is Novartis’ powerhouse of Global Clinical Operations, redesigned to enable faster trial recruitment and enhanced trial delivery resulting in more timely access for patients to potential novel treatments. Every day, we are the link between science and medicine - imagine the impact you could have as Contracting Specialist in the Study & Site Operations (SSO) team in Italy #GCO
Job Purpose:
The SSO Contracting Specialist reports into the Study Start Up (SSU) Team Lead and is accountable for coordination, preparation, and execution of clinical study contracts in close collaboration with SSO Study Start-Up Managers, SSO Clinical Project Managers and SSO Finance Specialists in compliance with Novartis processes, GCP/ICH and regulatory requirements.
As externally facing role, Your responsibilities include, but are not limited to:

- Supports country SSU strategy in close collaboration with Study Start-Up Team Lead and Study Start-Up Managers to ensure SSU timelines and deliverables are met according to country commitments
- Accountable for coordination, preparation, and execution of clinical study contracts and amendments in assigned projects.
- Negotiates financial & legal conditions, escalates issues as applicable. Tracks and oversees contract status incl. dispatch and return of contracts
- 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

**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**:

- Degree in scientific/health discipline with experience in clinical operations and/or project management, is preferable

Experience/professional Requirements:

- 1+ years of experience in clinical operations or equivalent
- Understanding of clinical drug development with particular emphasis on trial set-up, and contracting

Competencies:

- Demonstrated ability to problem solve and mediate complex issues
- Understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards

**Division**

Global Drug Development

**Business Unit**

GCO GDD

**Country**

Italy

**Work Location**

Milano

**Company/Legal Entity**

Novartis Farma IT

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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