Location: Prague, Czech Republic
Type: Full Time
Salary (CZK): Negotiable
108,000 people of more than 140 nationalities work at Novartis around the world. The Clinical Operations Specialist works with the Clinical Trial Team to ensure successful study conduct in collaboration with customer, other Line Functions and third-party vendors. You will be responsible for logistical aspects, vendor coordination and contribute to budget management of assigned clinical studies executed by NBS CONEXTS on behalf of Novartis Organizations and under the lead of Senior Clinical Project Manager (SCPM). NBS CONEXTS is an internal service organization and provides clinical project management services to a variety of Novartis customers. These may range from COS working within a customer team to COS working on a study that has been fully outsourced to NBS CONEXTS.
Your responsibilities include, but are not limited to:
• Responsible for evaluation of investigators fees (country level budget/Grant Plan) estimates per country and the negotiation of investigators fees and country related study costs; and supporting Clinical Project Manager (CPM) ensuring accurate planning, tracking and reporting of study budget.
• Support CPM in the set-up and coordination of third-party vendors (i.e. central lab, investigators’ meeting organization) and monitoring partner, ensuring all information, documentation and material in place for study start.
• Responsible for effective and smooth workflow between study participants (i.e. third-party vendors and monitoring partner) and follow-up with vendors and monitoring partners on day to day operations (recruitment reports, delivery of study kits …)
• Responsible for the set-up and maintenance of studies in Clinical Trial Management Systems (CTMS), ensuring all key documents are present and filed as appropriate in Trial Master File (TMF)
• Ensure availability of study material for monitoring partner/sites (i.e. IV bags, fridge, laptops, etc…) including tracking of rented material
• Support CPM in keeping overview of drug availability at site level in collaboration with monitoring partner and drug supply management
• Support CPM in meeting set-up, minutes, running reports from systems, draft study documentation
• Support CPM in study start up, recruitment and close out activities as required.
• Life Science degree or equivalent
• 6+ years’ operational experience of clinical study execution in a pharmaceutical company or contract research organization
• Strong technical and organizational skills, details oriented, thorough knowledge of Good Clinical practice and presentation and diplomacy skills
• Demonstrated ability to establish effective working relationship in a matrix and multicultural environment and willingness to act accountably in project/study management
• Strong customer oriented mindset and fluent English (oral and written)
• Exposure to finance processes & reporting
• Experience with forecast, actuals, cost reconciliation
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