REQ-10022400
Sep 16, 2024
Czech Republic

Summary

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.

About the Role

Key Responsibilities:

  • Evaluation of investigators fees (country level budget/Grant Plan) estimates per country.
  • 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.
  • 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...)
  • 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)
  • Ensuring availability of study material for monitoring partner/sites

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)

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 Cafeteria in the amount of 12,500 CZK per year; Meal vouchers in amount of 105 CZK for each working day (full tax covered by company); MultiSport Card, Employee Share Purchase Plan. Find out more about Novartis Business Services: https://www.novartis.cz/

Commitment To Diversity And Inclusion:

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

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

Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Operations
CTS
Czech Republic
Prague
Research & Development
Full time
Regular
No

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 [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.

A female Novartis scientist wearing a white lab coat and glasses, smiles in front of laboratory equipment.
REQ-10022400

Clinical Operations Specialist

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