Study Start-up Cra

Supports country SSU strategy in close collaboration with SSO Study Start-Up Team Lead, SSO Study Start-Up Manager, SSO Feasibility Manager as well as SSO Site Partnership Manager. Collaborates with SSO Study Start-Up Manager, SSO Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments
- Accountable for timely start-up activities from country allocation until site greenlight at assigned sites. Conducts site selection visits, verifies site eligibility for a specific study.
- Main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation. Ensures that milestones (KPIs) and time schedule for study start-up are met as planned
- Facilitates the preparation and collection of site and country level documents. Collects submission relevant site-specific documents (e.g., FD, CV, GCP certificates, DSL...) for all relevant site personnel within agreed timelines. Supports SSU Manager in preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
- Supports SSO Study Start-Up Manager and assigned sites in vendor set-up activities. Prepare and finalize site specific documents for submission. Negotiates investigator payments as needed. Supports preparation of financial contracts between Novartis and investigational sites and investigators as needed
- Updates all systems until site Green Light on an ongoing basis. Supports preparation of audits and inspections as applicable. Supports reduction of formal site-specific IRB/IEC deficiencies. Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness
- 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. Ensures sites are prepared for “Green Light” and is accountable to send the Green Light to SSU Manager for review and approval

**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**
- Strong interpersonal, negotiation and conflict resolution skills
- Ability to travel, e.g., for site selections, if applicable
- Ability to manage multiple priorities and manage time efficiently
- Fast change adaptability to best partner & influencing with sites on fast changing landscape
- Trust and rapport building is a very important skill needed
- Good communication

WHY NOVARTIS

769 million lives were touched by Novartis medicines in 2020, 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 & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

**Division**

Global Drug Development

**Business Unit**

GCO GDD

**Country**

Singapore

**Work Location**

Singapore

**Company/Legal Entity**

NOV SINGAPORE

**Functional Area**

Research & Development

**Job Type**

Full Time

**Employment Type**

Regular

**Shift Work**

No

**Early Talent**

No