Clinical Operations SpecialistNovartis Farmacéutica | Prague, NE, 68050, US
Posted a month ago
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 CONEXTS on behalf of Novartis Organizations and under the lead of Senior Clinical Project Manager (SCPM).
Your responsibilities include, but are not limited to:
• Responsible for evaluation of investigators fees (country level budget/Grant Plan) estimates per country. And responsible for 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.
• 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). 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
• Meeting set-up, minutes, running reports from systems, draft study documentation
• Support CPM in study start up, recruitment and close out activities as required
Diversity & Inclusion / EEO
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
What you’ll bring to the role:
• Life Science degree or equivalent
• 3+ 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
• Proven track record to establish effective working relationship in a matrix and multicultural environment and willingness to act accountably in project/study management
• Strong customer-oriented mentality and proficient English (oral and written)
Monthly pension contribution matching your individual contribution up to 3% of your gross monthly base salary; Risk Life Insurance (full cost covered by Novartis); 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 Benefit Plus 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/
Why consider Novartis?
766 million lives were touched by Novartis medicines in 2021, 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!
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
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 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.