Sso Study Start-up Manager

hace 6 meses

Buenos Aires, Argentina Novartis A tiempo completo

390776BR

**SSO Study Start-Up Manager**:
Argentina

**About the role**

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 Study Start-Up Manager is accountable for study planning, SSU activities and activation deliverables of assigned projects in compliance with Novartis processes, GCP/ICH and regulatory requirements in a standalone country, OPC (operating country) or satellite country. Leads all SSU activities of assigned projects in close collaboration with SSO Feasibility Manager and SSO Site Partnership Manager as well as the global study team. In satellite countries acts as primary back-up and deputy of the country manager.
Your responsibilities include, but are not limited to:

- Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio
- Collaborates with SSO Country / Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments
- Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects
- Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Country Head Portfolio / SSO Cluster Head Portfolio
- Collaborates with SSO Country / Cluster Head Portfolio, SSO Portfolio Team Leads and global study team to ensure SSU timelines and deliverables are met according to country commitments
- Accountable for timely start-up activities from country allocation until Green Light (ready to initiate site millstone) in assigned projects
- Oversees local SSU team activities in assigned studies to achieve start-up timelines and quality execution, (proposing and implementing corrective actions where appropriate), according to Novartis standards and local and international regulations
- Leads the development of country site initiation and patient enrolment plans together with SSU CRA, CPM and SSU Lead.

What you’ll bring to the role:

- Capable of leading in a matrix environment, without direct reports
- Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), local/National Health Authorities regulations and Novartis standards
- Strong interpersonal, negotiation and conflict resolution skills
- Communicates effectively in a local/global matrixed environment

What you’ll bring to the role:

- Capable of leading in a matrix environment, without direct reports
- Strong project management capabilities with demonstrated ability to problem solve and mediate complex issues
- Thorough understanding of the international aspects of drug development process, including strong knowledge of international standards (GCP/ICH), local/National Health Authorities regulations and Novartis standards
- Strong interpersonal, negotiation and conflict resolution skills
- Communicates effectively in a local/global matrixed environment

**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**

**Education**:

- A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable

Languages:

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

Experience/Professional requirement:

- Minimum 5 years’ experience in clinical operations in a role that oversees (project management) and/or with monitoring clinical trials

Desirable Experience & Qualifications:

- Strong interpersonal, negotiation and conflict resolution skills
- Communicates effectively in a local/global matrixed environment

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 & I

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