Senior / Clinical Project Manager

Redwood City  ‐ Onsite
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Keywords

Description

Principal Responsibilities:
  • Act as primary liaison to CROs and vendors for assigned clinical study programs, ensuring adherence to project scope, deliverables and timelines
  • Facilitate study start up with CROs and clinical sites
  • Organize and run assigned clinical study team meetings and teleconferences
  • Manage study logistics and monitoring activities to ensure that milestones and deliverables are well defined and achieved
  • Track and report clinical trial information and progress regarding patient recruitment, screening, monitoring, clinical and laboratory (PK/PD/ADA) data, data cleaning status for assigned clinical study/program, etc.
  • May conduct clinical site, CRO, and/or vendor monitoring visits and co-monitoring visits with CRO staff
  • Monitor the maintenance of the clinical trial master files per SOPs and GCP, at the CRO(s) and vendors.
  • Assist in the development of clinical project timelines to meet critical company milestones
  • Write or contribute to the development of clinical documents such as, clinical protocols, consent forms, Study Operations Plan, Monitoring Plan, Communication Plan, investigator brochure, clinical study reports, INDs/CTAs, marketing applications, annual regulatory reports, etc.
  • Coordinate the RFP process, review vendor proposals, and negotiate budgets for assigned clinical study/program
  • Assess feasibility for assigned clinical studies and contribute to the investigator/site selection process
  • Assist in the development, forecasting, monitoring, and reporting of assigned clinical study/program budgets


  • Contribute to the writing and implementation of Standard Operating Procedures (SOPs), standard forms and study-specific guidelines to support clinical operations
Start date
08/2014
Duration
temp to perm
From
Real Staffing
Published at
25.07.2014
Project ID:
747691
Contract type
Freelance
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