Country Trial Operations Lead (m/f/d)
Country Trial Operations Lead, Global Drug Development (GDD), Novartis Pharma, Vienna, Austria
500+ active trials with 80,000+ patients in 200+ programs! These are the figures of Global Drug Development (GDD) you will contribute as CSM & Trial Operations Lead based at Novartis in Vienna! As part of the Trial Monitoring Organization (TMO) team within GDD, this role is essential in ensuring Innovative Medicines Phase I-IV studies are initiated timely and in compliance with Novartis processes and regulatory requirements.
Your responsibilities include, but are not limited to:
• Lead local the Clinical Trial Associates (CTAs) team to ensure fast and good quality submission of initial clinical trial applications and subsequent updates to Health Authority (HA) and Ethics Committee (EC)
• Oversees the Country Trial Monitoring budget process and ensure appropriate controls are in place to deliver on Country Trial Monitoring business objectives
• Ensures the timeliness, accuracy and quality of Trial Master File (TMF) documents, including study activation and ongoing TMF maintenance in prep for TMF inspection readiness
• Is responsible for resource management of the CTA team and including the assessment and allocation of country resources to ensure a balanced workload across the team
• Manages and addresses Country Trial Monitoring performance targets per defined Trial Monitoring objectives, and serves as an escalation for study start up, drug supply, finance and business analytics management
• Ensures adherence to financial standards, prevailing legislation, GCP, Ethical Committee and SOP requirements
What you’ll bring to the role:
• University degree in life sciences (e.g. chemistry, biology, biotechnology or similar)
• Minimum of 5 years’ experience working in clinical research operations planning & execution
• Strong people management and team leadership skills
• Excellent knowledge 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
• Strong capability in working in a country matrixed environment
• Fluency in English and strong interpersonal, negotiation and conflict resolution skills
Knowledge of German will be considered a plus
Why consider Novartis?
750 million. That’s how many lives our products touched in 2019. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 24,164.00 per year on a full time basis).
Imagine what you could do at Novartis!
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Commitment to Diversity & Inclusion:
Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network