Contracting Specialist

3 months ago

West London, United Kingdom Novartis Full time

385971BR

**Contracting Specialist**:
United Kingdom

**About the role**

100,000+ That’s how many patients participate in our clinical trials at any given time. GCO 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 a Contracting Specialist #GCO
Must be able to work in London Office 12 days per month
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 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._

**Role Requirements**

Required Experience & Qualifications:

- Performance against study commitments at the country level, especially set-up/delivery of trials per defined contracting timelines and milestones (coordination, preparation, and execution of clinical study contracts and amendments)
- Delivery of study milestones in adherence to prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements.
- Timely submission and delivery of high-quality clinical trial documentation/data

Desirable:

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

**Why Novartis?**

**You’ll receive**:
Competitive salary, Annual bonus, Pension scheme, Share scheme, Health insurance, 25 days annual leave, Flexible working arrangements, subsidized dining facilities, Employee recognition scheme, learning and development opportunities.

**Join our Novartis Network**:
**Division**

Global Drug Development

**Business Unit**

GCO GDD

**Work Location**

London-West

**Company/Legal Entity**

Novartis Pharmaceuticals UK Lt

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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