Clinical Trial Manager - Oncology - Bay Area

Job type:
12 months
Real Staffing
South San Francisco
flag_no USA
project ID:

This project is archived and not active any more.
You will find vacant projects in our project database.
Primary Responsibilities:
  • Responsible for conducting clinical programs consistent with applicable regulations, guidelines, and policies. Ensures study adherence to ICH/GCP and SOPs
  • Research, prepare, and revise the study protocol, Monitoring Plans, Informed Consent/Assent Forms, Case Report Forms, etc., in consultation with the cross-functional project team, investigators, data management, and biostatistics.
  • Prepares clinical documents for IRB/EC submissions.
  • Prepares training materials for investigators, site staff, and clinical staff. Conducts site initiation and monitoring activities as necessary.
  • Develops project timelines. Develops and manages study budgets. Ensures appropriate resources and priorities are maintained for the various projects assigned to their area.
  • Assists Data Management, as required, with review of clinical data/information and provides oversight of data correction as necessary.
  • Manages activities performed by Contract Research Organizations or other vendors.
  • Able to evaluate clinical data/information and write, review or revise clinical sections of annual, interim, and final reports, and clinical sections of regulatory submissions as necessary or requested.
  • Provides the day-to-day operational management of CROs and vendors to ensure delivery against contracted scope of work, including negotiation of scope of work, budgets, performance management, and issue resolution.
  • Assists the Senior Director and/or Quality group with SOPs and training requirements.

Skills and Experience:
  • Bachelors Degree required; Life Sciences Preferred
  • Driven to deliver results with the ability to establish rapport, earn trust, and effectively collaborate with others.
  • Proven clinical development experience of the operational aspects of all stages of clinical studies, preferably working in a global environment and/or including monitoring, leading clinical subteams, working with vendors and CROs, managing drug supply, and planning operational activities to achieve database lock.
  • Experienced in project management, including development of timelines, budgets and resource plans.

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