Clinical Study Manager - Oncology

Location
Princeton, NJ
Posted
May 07, 2017
Institution Type
Outside Academe


Job Description

Summary of Job: Responsible for the management of the execution of the assigned clinical trial(s). Serves as the leader and coordinator for the implementation of all clinical trial activities. Contributes to the long term development goals of the assigned project(s) in collaboration with senior management.
  • Serves as the leader and coordinator for the execution and management of the clinical trial(s)
  • Leads the study team's identification and selection of CROs, service-specific vendors, KOLs and investigational sites
  • Manages the CROs and service-specific vendors in the initiation, management and completion of clinical studies according to ICH, GCP and company SOPs
  • Manages the study team's deliverables in accordance with the study timelines
  • Manages and reports study milestones, status updates and alerts project team of potential delays
  • Initiates the team's development and implementation of risk mitigation strategies
  • Provides clinical input into cross-functional activities
  • Manages the overall quality of the study data
  • Provides clinical input and manages the study team's development of the key study documents, including the study protocol, IB, SAP and CSR
  • Leads the completion of clinical sections for regulatory filings, e.g. NDA, DSUR
  • Provides study specific training and education for internal and external project team members
  • Identifies and assists in streamlining and standardizing departmental policies/procedures
  • Position requires approximately 10% domestic and possibly international travel

Job Requirements:
Education
:
Position requires a minimum of a Bachelor's degree, preferably in health/medical related field or life sciences area

Experience:
5+ years of clinical trial management experience in the pharmaceutical or biotechnology industry, with emphasis in oncology clinical trials. Experience in Phase 1 solid tumor oncology trials preferred.
Must possess a strong understanding of clinical drug development, GCP and the regulatory requirements for clinical trials
Must have a thorough understanding of clinical study design, CRF design, project management and data handling
Must have experience managing CROs and service-specific vendors



Princeton, NJ

c73aab1e44

Sat, 6 May 2017 06:24:27 PDT

PI97773345