Clinical Trial Manager

Description

• Manage external vendors and contract research organizations
• Prepare study documents such as the Monitoring Manual, Study Operations Manual, Source Data Verification Plan and Laboratory Manual
• Coordinate and be responsible for the design of study materials such as CRFs, patient diaries, study participation cards and source documents
• Assist with protocol development and study report completion
• Manage monitoring activities (may include routine on-site clinical monitoring) at clinical study sites to assure adherence to Good Clinical Practices (GCPs), SOPs and study protocols
• Provide guidance, direction, and management to CRAs
• Track patient enrollment; qualify, initiate, monitor, perform closeout activities, and review site reports; and assist in coordination of data management activities
• Coordinate study supplies
• Negotiate contracts with vendors of clinical trial services
• Review Informed Consent Forms, CRFs, and study related materials
• Plan and participate in investigator meetings
• Assist and support data query process
• Assure regulatory compliance of investigational sites with company SOPs and FDA and ICH guidelines
• Ensures trial master file is current and maintained

• BA/BS, nursing degree, or advanced degree. Degree in the life sciences preferred
• Seven or more years of relevant clinical trials experience, with at least four years of experience as a CRA in the pharmaceutical industry (i.e. biotechnology, pharmaceutical, CRO, medical device)
• Must be willing to travel 30-50%
• Demonstrated working knowledge of GCP, ICH guidelines and FDA regulations
• Demonstrated ability to work independently and in a team environment
• Proficiency with MS Office (e.g. Word, Excel, PowerPoint, Outlook)
• Excellent oral and written communication skills and strong organizational abilities
• Experience in CNS and / or Oncology is preferred