Clinical Program Manager

Emeryville  ‐ Onsite
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Keywords

Description

Specific responsibilities:
  • Develop and manage study timelines, milestones and budgets in collaboration with trial team members.
  • Develop study protocols with guidance from Medical Monitor.
  • Develop case report forms, informed consent forms and other study-related documents.
  • Selection and qualification of investigational sites.
  • Participate in selection of, management and oversight of CROs and other vendors to ensure that clinical studies are executed properly, on time and in compliance with GCPs.
  • Review and approve vendor and site invoices.
  • Manage external resources, as required.
  • Conducts site evaluations, initiation, monitoring, and closeout visits, as required.
  • Contributes to Clinical Study Reports, NDAs, and other clinical, regulatory, and safety documents - ensuring reports are controlled for quality, signed off and published with copies going to Regulatory Authorities and Ethics Committees, as required.
  • Collect and archive documents for inclusion in the Trial Master File.
  • Ensure study compliance by understanding and applying all relevant SOPs.


Qualifications:
  • Minimum of a Bachelor of Science degree in a relevant scientific discipline
  • 4 - 6 years experience (CRO or pharmaceutical company), with a minimum 2 years experience managing external vendors. Thorough knowledge of planning, implementing, and managing single and multi-center clinical trials is required. CNS experience is preferred and international study experience is a plus.
  • Strong written and verbal communication, interpersonal, problem solving and negotiation skills.
  • Good presentation skills: ability to present to diverse groups of clinical staff (internal and external). Proven organizational skills; ability to manage multiple priorities and work under pressure.
  • Computer software: Microsoft Word, Excel, PowerPoint, Project, Visio
  • Ability to travel


To find out more about Real please visit www.realstaffing.com
Start date
04/2014
From
Real Staffing
Published at
10.04.2014
Project ID:
692833
Contract type
Freelance
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