G1 Therapeutics
  • Durham, NC, USA
  • Full Time

G1 Therapeutics is seeking an experienced Clinical Operations Lead to join the Clinical Operations Team.

Responsibilities:

  • Work closely with Manager/Sr. Manager/ Director regarding study conduct activities which includes reviewing invoices from vendors and participate in quarterly budget review meetings with Product Development Outsourcing (PDO) department
  • Responsible for managing the day-to-day clinical trial activities with the CRO and management of 3rd party vendors, laboratory vendors, etc.
  • Point of escalation for questions from CROs, 3rd party vendors, sites, etc.
  • Responsible for reporting escalation issues to Sr. Manager or Clinical Operations Director/department head
  • Review KPI/Metrics from CROs and distribute to team
  • Track and prepare study- specific information utilizing databases, spreadsheet and other tools
  • Responsible for addressing questions from CRO CRA team members, attend co-monitoring visits at study sites
  • Review of trip reports from CRO vendors or delegation of this activity to junior study team members
  • Work closely with cross functional department (PDO, CMC, Biometrics, Clinical Development, Regulatory Affairs, and Quality)
  • Ensure adequate Clinical Trial Material/IP is adequate at sites and study forecasts are in line with CMC estimates
  • Participate in internal and external team meeting, prepare agendas, meeting minutes, provide team updates
  • Responsible for the development of the study template Informed Consent Form (ICF) document, updates to the ICF
  • Review and provide feedback as needed to key study documents, such as Study Protocol, Amendments, Investigator's Brochure, DSUR, IMPD, CSR, etc.
  • Review/Approve site specific essential documents from CRO to authorize release investigational product (IP) for study conduct.
  • Responsible for draft/review/approval of the development, assembly and distribution of study documents, manuals and tools in collaboration with our CRO partner
  • Assist with development of new or updating existing Standard Operation Procedures for the department.
  • Travel to sites when necessary (25%)

Requirements:

  • BA/BS degree or equivalent; health science degree or biologic science degree is preferred. A minimum of 5 years' experience in the pharmaceutical industry, with minimum 4 years direct experience in monitoring and managing study sites. Oncology experience highly preferred.
  • Significant experience with responsible roles in the conduct or management of Phase I III clinical trials.
  • Must have a good working knowledge of medical terminology, physiology and pharmacology and an excellent knowledge of applicable U.S.; international regulations and guidelines, is preferred, but not required.
  • Excellent oral and written communication, organizational and planning skills are required, ideally with the ability to manage budgets.
  • Detail-oriented, a self- starter and be comfortable with broad responsibilities in an
  • entrepreneurial, fast-paced, small company environment.

G1 Therapeutics provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. G1 Therapeutics complies with applicable state and local laws governing non-discrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including, but not limited to, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.

G1 Therapeutics
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