Sso Clinical Project Manager

hace 2 semanas

Barcelona, España Novartis A tiempo completo

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 CPM #GCO
This is a completely new and exciting strategic opportunity where enterprise, agility, autonomy, quality, and superior project management of clinical trial execution are at its core The CPM is the single point of contact and study team lead, within the country/cluster/hub, for the assigned studies and countries. The CPM is responsible for assuring aligned communication with Trial Lead and other CTT members, locally with Clinical Research Associates (CRAs), CRA Managers and other key associates on the execution and progress of their studies in all assigned countries. If you are interested in bringing value for our patients, being a part of our family environment, focused on reduced cycle time and costs, then you should apply.
Your key responsibilities:

- Supports SSO Study Start-up Manager in the development of country/cluster/hub study execution plans and timeline commitments
- Participates in the recruitment sub-team and supports the development of innovative solutions for site and patient participation to ensure the delivery of assigned studies on time
- When requested by the SSO Feasibility Manager supports the study feasibility by providing input to the study protocol, and operational aspects of the study
- Maintains a strong knowledge of the study protocol to answer standard operational questions from CRAs, sites and Country/Cluster/Hub personnel
- Conducts or coordinates training, as needed, for CRAs to support site readiness to recruit and study execution ensuring adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
- Conducts or coordinates local investigator meetings as needed and ensures relevant documentation of training is archived in the Trial Master File
- Monitors the status of site budget and contract negotiations as well as the collection and review of essential documents throughout study conduct
- Tracks study budget with appropriate study budget responsible in Country. Ensures timely TCF preparation and submission

**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**

What you’ll bring to the role:

- Timely submission and delivery of high-quality clinical trial documentation/data
- Performance against study commitments at the country/cluster/hub level, including delivery of studies per defined timelines (including study close out), number of patients and quality
- Delivery of study milestones in adherence to prevailing legislation, GCP, Ethical Committee and SOP requirements

Desirable requirements:

- Minimum 5 years’ experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
- 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), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards

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 achieve here at Novartis
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.
Accessibility and accommodation

**Division**

Global Drug Development

**Business Unit**

GCO GDD

**Country**

Spain

**Work Location**

Barcelona Gran Vía

**Company/Legal Entity**

Novartis Farmacéutica, S.A.

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No

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