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Investigator-Sponsored Study Program Manager

New Jersey All, NJ

Posted: 02/07/2019 Job Type: Clinical Job Number: JN -022019-23631
  • Manage investigator-sponsored study operations and ongoing quality improvements in the processing and review of ISSs
  • Liaise with field medical teams, medical units, legal, and other departments as needed to ensure investigator sponsored trial requirements are met or exceeded
  • Responsible for driving the timely execution of contracts and financial payments, budgeting and financial forecasting, tracking of ISS study progression, management of the ISS database, and for maintaining ongoing metrics and reports on a regular basis
  • Compliance with ISS SOPs, processes, systems and regulations and participation in improvement initiatives, taskforces, and committees to improve ISS processes
  • Ability to educate others on ISS SOPs and processes, identify compliance issues and escalate accordingly to senior management
  • Liaise directly with sponsor-investigators and ISS Review Committee members, including Medical Directors, Regional Medical Liaisons, Pharmacovigilance, Biostatistics, Legal/Regulatory and Clinical Supplies
  • Actively participate in the review and evaluation of investigator-sponsored trial submissions for compliance with company policy and alignment with corporate strategy
  • Track the execution of the ISSs and budgets from approval decision
  • Critically evaluate budgets for proposed ISSs, including accountability of accurate forecasting of ISS milestone payments
  • Maintain an accurate and current database on the status of all ISSs
  • Forecasting study drug requirements to Clinical Supplies and arranging for shipping and monitoring of study drug supply
  • Accountable for ISS records and history to be audit ready
  • Identifies when issues should be escalated to ISS/Medical Operations management and seeks input from appropriate team members
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