Study Start-up Clinical Research Associate

hace 2 semanas

Madrid, España Novartis A tiempo completo

395138BR

**Study Start-Up Clinical Research Associate (Remote)**:
Spain

**About the role**

**Location**:This is a remote, field based role with an average number of 2/3 site visits per week across Spain.
As our **Study Start-Up CRA** your role has a high impact for Novartis. This exciting role covers everything from early identification of real site needs and issues, to closing handover to execution CRA for all sites. By building the site relationship management you will ensure a sustainable trial start-up at site. This role will work directly with the Study Start-Up Team and reports to the Study Start-Up Team Lead.
**Key Responsibilities**:

- Accountable for timely start-up activities from country allocation
- Conduct site selection visits, verify site eligibility for a specific study
- Main contact for trial sites during site selection
- Ensure that milestones (KPIs) and time schedule for study start-up are met as planned
- Facilitate the preparation and collection of site and country level documents
- Support team and assigned sites in vendor set-up activities
- Negotiate investigator payments as needed
- Support preparation of financial contracts between Novartis and investigational sites and investigators as needed
- Implement 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**:

- A degree in Scientific or Health Discipline.
- Sufficient Clinical Operations Experience.
- Advanced understanding of all aspects of clinical drug development with particular emphasis on trial set-up, execution, and monitoring.
- Strong knowledge of international standards (GCP/ICH), Health Authorities (FDA/EMA), local/National Health Authority regulations.
- Ability to travel for site selections.
- Fluent Spanish (Both spoken and written)
- Proficient English (Both spoken and written)

**Desirable Skills**:

- Central/in-house monitoring or field monitoring experience would be an advantage.

**Division**

Development

**Business Unit**

GCO GDD

**Work Location**

Madrid

**Company/Legal Entity**

Novartis Farmacéutica, S.A.

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

Yes

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