Sso Contracting Specialist
5 months ago
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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