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Sr. Clinical Trial Manager

Job Title: Sr. Clinical Trial Manager
Contract Type: Contract
Location: Pennsylvania, United States
Industry:
Salary: Competitive
Start Date: 2019-02-26
Reference: BH-102819
Contact Name: Jeff Armand
Contact Email: jeff.armand@redbock.com
Job Published: February 26, 2019 17:39

Job Description

A Biopharmaceutical company focused in sleep and hematology/oncology is looking for a Sr. Clinical trial manager to lead them through a phase three study. Candidates can work onsite in Philadelphia or Palo Alto. Candidates must be on-site Monday-Friday (Fridays people typically work from home). The type of study is a phase three study global study for PVOD. There will be no Trial Master Files to manage.
Day to day functions of this role will include:
  • 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 SOPs and FDA and ICH guidelines
  • Ensures trial master file is current and maintained
Minimum Requirements
  • 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)
  • Travel required.
  • 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