Clinical Trial Manager

South San Francisco  ‐ Onsite
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Keywords

Description

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.


To find out more about Real please visit www.realstaffing.com
Start date
04/2014
From
Real Staffing
Published at
11.04.2014
Project ID:
693607
Contract type
Freelance
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