Sso Contracting Specialist

2 weeks ago

Sydney, Australia Novartis Full time

393037BR

**SSO Contracting Specialist**:
Australia

**About the role**

Internal Role Title: SSO Contracting Specialist
Location: Sydney, Australia #LI-Hybrid
About the Role:
The SSO Contracting Specialist is accountable for coordination, preparation, and execution of clinical study contracts (PI, site, institution, MSA, local vendors, etc. as applicable) in a direct country or extended country group (OPC and satellite countries) 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
Key Responsibilities:
- Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead and SSO Study Start-Up Managers to ensure SSU timelines and results are met according to country commitments.
- Accountable for coordination, preparation, and execution of clinical study contracts and amendments (PI, site, institution, MSA, local vendors, etc. as applicable) in assigned projects.
- Tracks and is responsible for contract status incl. dispatch and return of contracts.
- Negotiates financial & legal conditions, brings up issues as applicable.
- Single point of contact for local Legal and ERC (e.g., for patient reimbursement topics)
- Develops and standardizes local contract templates (e.g., for EC submission if required by local regulation) and MSAs.
- 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**:

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

**Role Requirements**

Essential Requirements:
- Commercial or medical training (e.g., vocational qualification) or a degree in scientific or health field with experience in clinical operations and/or project management
- 1+ years of experience in clinical operations or equivalent
- Understanding of clinical drug development with particular emphasis on trial set-up, and contracting
- Proven ability to problem tackle and mediate sophisticated issues
- Understanding of the international aspects of drug development process, including solid understanding of international standards (GCP/ICH), health authorities (FDA/EMEA), local/National Health Authorities regulations and Novartis standards
- Strong interpersonal, negotiation and conflict resolution skills
- Independent, dynamic, structured and committed way of working.
- Communicates effectively in a local/global matrixed environment.

Why Novartis?

**Division**

Development

**Business Unit**

GCO GDD

**Work Location**

Sydney

**Company/Legal Entity**

AU Pharma Pty Ltd

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes

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