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Clinical Operations Specialist

cndjobs

Last Updated: 4/24/21

Job Description

Dear Job Seekers,

Novartis is Hiring for:

Job Title: Clinical Operations Specialist

Job Description:

  • Trial budget management Responsible for evaluation of investigators fees (country level budget/ Grant Plan) estimates per country and the negotiation of investigators fees and country related trial costs. Support
  • Trial Manager ensuring accurate planning, tracking and reporting of trial(s) budget. Vendors coordination Once agreement in place, support trial Manager in the set-up and coordination of third-party vendors (i.e., central lab, investigators meeting organization) ensuring all information, documentation and material in place for trial start.
  • Responsible for effective and smooth workflow between trial participants (i.e., third-party vendors and country/sites management).
  • Follow-up with vendors on day-to-day operations (recruitment reports, delivery of study kits ) Monitor status of final invoices Trial logistics
  • Responsible for the set-up and maintenance of trial(s) in Clinical Trial Management Systems: For trial timelines and key milestones, enrolments, sites information as appropriate (i.e., Clinamen), generate enrolment curves to support reporting
  • Project files up to date in CREDI (all study related documents on top of protocol and amendments). Checking countries and HQ TMF, ensuring all key documents are present and filed as appropriate. Final Protocol Packages availability.
  • Ensure availability of trial material for country management /sites (i.e., IV bags, fridge, laptops, etc) including tracking of rented material.
  • Support Trial Manager in keeping overview of drug availability at site level in collaboration with country management and drug supply management.
  • Support Trial Mgrs. in meeting set-up, minutes, running reports from systems, draft trial documentation
  • Minimum requirements At least 6 years operational experience of clinical study execution in a pharmaceutical company or contract research organization. Life Science degree or equivalent
  • Exposure to finance processes & reporting a plus. Fluent English (oral and written).
  • Experience in finance: forecast, actuals, cost reconciliation, a plus. Strong technical and organizational skills (excel, MP,), Details oriented.

Experience: 6 years

Salary: As per the Company Standards

Location: Gurgaon



Company Details

Hyderabad, Telangana, India