Sso Contracting Specialist

5 months ago


Montréal, Canada Novartis Full time

100,000. That’s how many patients participate in our clinical trials at any given time. Global Clinical Operations (GCO) touches patients’ lives every day acting as a link between science and medicine. Envision the impact you could have #GCO
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.
Your responsibilities include, but are not limited to:

- 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 deliverables 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 oversees contract status incl. dispatch and return of contracts
- Negotiates financial & legal conditions, escalates 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._

**Minimum requirements**

Required Experience & Qualifications:
**Education**:

- Commercial or medical training (e.g., vocational qualification) or a degree in scientific or health discipline with experience in clinical operations and/or project management

Languages:

- Fluent in both written and spoken English, local language as needed.

Experience/Professional requirement:

- 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
Other Desired Skills & Knowledge:

- Strong interpersonal, negotiation and conflict

resolution skills
- Independent, dynamic, structured and committed way

of working
- Communicates effectively in a local/global matrixed

environment
GCO

**Division**

Global Drug Development

**Business Unit**

GCO GDD

**Country**

Canada

**Work Location**

Montreal

**Company/Legal Entity**

Novartis Pharma Canada

**Functional Area**

Audit & Finance

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No



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