Job Description

Study and Site Country Manager (Satellite Country)

100,000+ That\xe2\x80\x99s how many patients participate in our clinical trials at any given time. GCO is Novartis\xe2\x80\x99 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 \xe2\x80\x93 imagine the impact you could have as Study and Site Country Manager! #GCO

The Study and Site Operations (SSO) Country Manager is accountable for all country clinical operation activities related to the allocation, initiation, conduct (recruitment, quality data collection) and timely completion of Phase I-IV Oncology and Pharma clinical trials. The SSO Country Manager is responsible for implementing the Study & Site archetype and Hub/Cluster/Country strategy, while delivering to Country budget and productivity targets in line with Study & Site and local business objectives. Operationally responsible for building a high performing team culture and including performance management and established monitoring procedures in accordance with GCP, ICH and local regulations.

Your key responsibilities, but not limited to:

• Responsible for the alignment between SSO Feasibility Manager and relevant medical/clinical functions to ensure strategic allocation and execution of global development trials within the Country (Innovative Medicines Phase I-IV trials)
• Drive collaborative engagement model with Cluster Head Portfolio to ensure Country participation in GDD trials is aligned with the overall OPC Country structure portfolio execution strategy
• Ensure Country trial site selection, activation, enrolment, resource allocation, timelines and budget commitments are delivered per established trial objectives
• Build and maintains effective site relationship management to ensure site performance to trial commitments and delivery of quality monitoring
• Actively monitors the KQI\xe2\x80\x99s and develops, maintains and follows-up on the yearly process control plan in the Country to ensure adherence to clinical data standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
• Is responsible for Country Monitoring issue identification, escalation and resolution pathways in CPO, partnering with relevant medical/clinical functions, Country QA, GLF\xe2\x80\x99s and Dev QA
• Actively manages Country issue identification and resolution in relation to CPO and trial audits, inspections and delivers to CAPA implementation requirements
• Promotes a compliance culture advocating the adherence to highest standards and ethical integrity, ensuring human subject protection and reliability of trial results at all times

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
Desirable requirements:

• Minimum 8 years\xe2\x80\x99 experience in clinical research - planning/executing and/or monitoring clinical trials with minimum 4 years in a people management role
• Expert understanding of all aspects of clinical drug development with particular emphasis on trial execution and monitoring
• Thorough understanding of the international aspects of drug development process, including expert knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National Health Authorities regulations and Novartis standards
• Excellent communicator and presenter (oral and written), ability to communicate to Sr. Leaders
• Fluent in both written and spoken English
• Bachelor\xe2\x80\x99s Degree in life sciences required, Advanced Degree in life sciences or business

preferred

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we\xe2\x80\x99re proud of this, we know there is so much more we could do to help improve and extend people\xe2\x80\x99s 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\xe2\x80\x99s 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\xe2\x80\x99 representative of the patients and communities we serve.

Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to all individuals. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to receive more detailed information about the essential functions of a position, please send an e-mail to diversity.inclusion_ch@novartis.com and let us know the nature of your request and your contact information. Please include the job requisition number in your message. #GCO
Division
Global Drug Development
Business Unit
GCO GDD
Country
Malaysia
Work Location
Petaling Jaya
Company/Legal Entity
NOV MALAYSIA
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
Early Talent
No