Clinical Trial Manager

Job type:
on-site
Start:
07/2014
Duration:
n.a
From:
Real Staffing
Place:
South San Francisco
Date:
07/12/2014
Country:
flag_no USA
project ID:
740698

Warning
This project is archived and not active any more.
You will find vacant projects in our project database.
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.
  • Interfaces with representatives from key functional groups (Research & Development, Biometrics Regulatory Affairs, Marketing, etc. to drive clinical-wide or cross-departmental initiatives.
  • 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.
  • Works with appropriate departments to control IP allocation, distribution, and reconciliation.
  • 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 input and support for post-clinical activities and market launch of products.
  • Coordinates with Regulatory Affairs to prepare responses to study questions or issues from Health Authorities or IRBs/IECs
  • 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.
  • Identifies areas of best practice and process improvements
  • Assists the Senior Director and/or Quality group with SOPs and training requirements
  • Participates in Clinical Operations initiatives and programs as assigned.
  • Maintains oversight and ensures consistency of the operational aspects across studies within a project.


Job Requirements:
  • 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.