Connecting...

W1siziisimnvbxbpbgvkx3rozw1lx2fzc2v0cy9zy2lwcm8vanbnl2pvyl9kzwzhdwx0x2jhbm5lci5qcgcixv0

Clinical Trial Manager

Clinical Trial Manager

Job Title: Clinical Trial Manager
Contract Type: Permanent
Location: San Francisco, California
Industry:
Salary: Negotiable
Reference: TrialManKM_1502814140
Contact Name: Kyle Murfin
Contact Email: k.murfin@sciproglobal.com
Job Published: August 15, 2017 17:22

Job Description

Clinical Trial Manager - South San Francisco

Description:

Leads activities associated with the evaluation, initiation and management of clinical studies to ensure compliance with SOPs, FDA regulations and ICH/GCP guidelines. Leads study management team, including oversight of CRO and Vendors. Coordinates the training of staff involved in clinical trial management. Provides training to clinical operations staff and performs performance appraisals of direct reports.

Responsibilities:

  • Responsible for the preparation and finalization of project and study-related documents including: informed consent forms, clinical trial outlines, monitoring plans, synopses, protocols and amendments, IND Annual Updates and clinical summaries, as required.
  • Responsible for the selection of investigators and study sites.
  • Responsible for identifying and responding to site and study related issues and recommending corrective actions and/or escalating to supervisor.
  • Coordinates the design, format and content of CRFs, study guides, study reference binders, patient diaries, and forms including participating in the EDC and IVRS specification process and UAT.

Requirements:

  • BA/BS/MS in a scientific discipline.
  • 7+ years of relevant clinical experience in a CRO or pharmaceutical.
  • At least 3 years of CRA experience and 2 years of study management experience.
  • Experience in oncology preferred.

Clinical Trial Manager - South San Francisco