Sso Clinical Project Manager

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 Clinical Project Manager #GCO
This position is open to associates in Singapore, South Korea, Taiwan, Australia and India.
The SSO Clinical Project Manager (CPM) is accountable for the day-to-day planning, executing and reporting, (from first site initiation visit to and including study site close-out), of assigned Global Drug Development (GDD) studies in compliance with Novartis processes and regulatory requirements.
The CPM is the single point of contact and study team lead, within the country/cluster/hub, for the assigned studies. 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. The CPM collaborates with the SSO Country Manager, SSO Country Head, SSO Feasibility Manager, SSO Study Start-up Manager and SSO Site Partnership Manager in the planning, execution, and delivery of their assigned studies. Accountable for execution and reporting of assigned GDD studies in E2E product line Clinical Operations Program Head/Study Lead/ CPM - CRA. Can be assigned partially to participate in the review process of Site Monitoring Plans across Portfolio.
Study & Site Operations strategy:

- 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

Initiation and conduct of trials:

- 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

Delivery of quality data and compliance to quality standards:

- 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

Budget and productivity:

- 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

Activities & Interfaces:

- Core member of Global Clinical Trial team as Country and Hub representative responsible for all local level feedback to the global trial execution teams.
- Interfaces with SSU teams to ensure on-time initiation of all sites within geography.

**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**
- A degree in scientific or health discipline required and advanced degree with clinical trial experience and/or project management, is preferable
- Fluent in both written and spoken English
- Minimum 5 years’ experience in clinical research in a role that oversees (project management) and/or with monitoring clinical trials
- Capable of leading in a matrix environment, without direct reports and working cross-border managing study in various countries
- Understanding of all aspects of clinical drug development with particular emphasis on monitoring and study execution
- 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
- Demonstrated negotiation and conflict resolution skills both internal and external (site relationships)

**Division**

Global Drug Development

**Business Unit**

GCO GDD

**Country**

Singapore

**Work Location**

Singapore

**Company/Legal Entity**

NOV SINGAPORE

**Alternative Country 1**

Australia

**Alternative Country 2**

India

**Alternative Country 3**

Taiwan

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**