Location: Prague, Czech Republic
Type: Full Time
Salary (CZK): Negotiable
108,000 people of more than 140 nationalities work at Novartis around the world. You will be responsible for clinical execution and management of all aspects of assigned clinical studies (interventional and non-interventional, from early phase to late phase). You will be working with the Sr. CPM (where applicable), Clinical Operations Specialist (COS) and Team leading the planning and implementation of all operational aspects of assigned clinical studies from study concept to reporting/manuscript writing, according to timelines, budget, operational and quality standards (ICH/GCP/SOPs and procedures). NBS CONEXTS is an internal service organization and provides clinical project management services to a variety of Novartis customers. These may range from CPM working within a customer team to CPM leading a study that has been fully outsourced to NBS CONEXTS.
Your responsibilities include, but are not limited to:
• Lead and manage a multidisciplinary cross functional Clinical Trial Team (CTT) (medical writing, statistics, data management, monitoring partner, drug supply, regulatory, safety etc.) or support the Sr. CPM (where applicable) to ensure study deliverables are met according to timelines, budget, quality standards and operational procedures
• Responsible for investigators meeting organization and all internal meetings related to the clinical trial execution and operational excellence
• As applicable, directly interact with investigator sites and CRAs/CROs/vendors to ensure smooth study set up and smooth study conduct, reviewing site performance, protocol deviations, ongoing risk assessment and timely issue resolution
• In collaboration with the NBS CONEXTS or Customer data review team (Central data Monitors, Data Managers, Statisticians, and third parties), contribute to the study data ongoing medical/scientific quality review to ensure high quality data are transferred/available in a timely manner.
• Coordinate the data analysis and interpretation for first interpretable results (where applicable) with the NBS CONEXTS or Customer Medical Representative
• Responsible for Clinical Study Report, either directly contributing to or managing the report writing, or by liaising with the NBS CONEXTS or customer medical writing/narrative group to ensure report is completed according to current requirements
• In partnership with Clinical Operations Specialists (COS) (where applicable) responsible for the set up and maintenance of the Trial Master File (TMF) and Clinical Trial Management System (CTMS) for studies
• Work with CTT and QA to identify potential issues and implement actions to resolve them
• Advanced degree or equivalent education/degree in life science/healthcare is required
• 8 years’ Clinical Operations experience with at least 4 years managerial experience in planning, executing, reporting and publishing clinical studies (interventional and non-interventional clinical studies, early to late phase) in a pharmaceutical company or contract research organization
• Thorough knowledge of Good Clinical Practice, clinical study design, statistics, regulatory processes, and global clinical development process
• Demonstrated presentation skills, diplomacy skills; negotiation and conflict resolution skills, strong customer oriented mindset and the ability to resolve issues with minimal supervision and understand when to escalate
• Proven ability to work independently in a complex matrix environment (including remote) and fluent English (oral and written)
Monthly pension contribution matching your individual contribution up to max 3% of your gross monthly basic salary; Risk Life Insurance and insurance in case of long term sickness; 5-week holiday per year; (1 week above the Labour Law requirement) ; 4 paid sick days within one calendar year in case of absence due to sickness without a medical sickness report; Cafeteria employee benefit program – choice of benefits from Edenred CZ in the amount of 12,500 CZK per year; Meal vouchers in amount of 90 CZK for each working day (full tax covered by company); Public Transportation allowance; MultiSport Card. Find out more about Novartis Business Services: https://www.novartis.cz/
799 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.
Imagine what you could do at Novartis!
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.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.
Na Pankráci 1724/129, 140 00 Praha-Nusle, Czech Republic