Sso Contracting Specialist
hace 7 días
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-UpManagers 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**:
- Novartis is 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
**Desirable Experience & Qualifications**:
- Strong interpersonal, negotiation and conflict resolution skills
- Independent, dynamic, structured and committed way of working
**#GCO**
**Why Novartis?**
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying
Imagine what you could do here at Novartis
**Commitment to Diversity & Inclusion**:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
**Division**
Global Drug Development
**Business Unit**
GCO GDD
**Country**
Argentina
**Work Location**
Buenos Aires
**Company/Legal Entity**
Novartis Argentina S.A
**Functional Area**
Research & Development
**Job Type**
Full Time
**Employment Type**
Regular
**Shift Work**
No
**Early Talent**
No
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