394159BR
Mar 14, 2024
Czech Republic
About the Role
Location: Prague, Czechia #LI-Hybrid
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
About the Role:
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.
Key Responsibilities:
• 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
Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.
About the Role:
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.
Key Responsibilities:
• 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
Diversity & Inclusion / EEO
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Role Requirements
Essential Requirements:
• 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 tact skills
• Consistent track record to establish effective working relationship in a matrix and multicultural environment and willingness to act accountably in project/study management
• Strong customer focused mentality and proficient English (oral and written)
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: 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/
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
• 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 tact skills
• Consistent track record to establish effective working relationship in a matrix and multicultural environment and willingness to act accountably in project/study management
• Strong customer focused mentality and proficient English (oral and written)
Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: https://www.novartis.com/about/strategy/people-and-culture
You’ll receive: 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/
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Operations
Global Business Solutions
Czech Republic
Prague
NOV CZE
Research & Development
Full Time
Regular
No
