Clinical Project Manager in Burnaby at Apex Life Sciences

Date Posted: 4/5/2018

Job Snapshot

Job Description


Our client is a research-oriented pharmaceutical company located in Vancouver, BC.  They are currently seeking an experienced Clinical Project Manager to oversee clinical trials from early (phase 1 and 2) to late stage.  Candidates who are local and can work on-site are preferred due to highly collaborative team environment at this company.  Occasional travel to different sites is required.

RESPONSIBILITIES:

  • Responsible for providing clinical project management support and the completion of assigned activities related to multiple clinical projects, a number of preclinical stage projects and multiple secondary assignments, such as compiling and evaluating literature etc.
  • Works with all relevant groups (internal and external) to ensure all assigned activities are managed appropriately
  • Develops and implements plans (including budgets and timelines) for assigned projects, studies and activities
  • Prepares Requests for Proposals, coordinates the evaluation of the proposals, and provides input into the selection of clinical service providers
  • Actively participates in all aspects of project development, including the coordination, writing, review and finalization of clinical trial protocols, consent forms, case report forms, study plans, and other essential regulatory documents
  • Assists with the selection of qualified investigators and study sites
  • Acts as primary point of contact for clinical service providers
  • Manages clinical trial budgets, timelines, and data safety review processes
  • Oversees adherence to applicable regulations, recognized guidelines, clinical trial protocol, and standards of clinical practice
  • Works collaboratively within a team environment and interacts with clinical and nonclinical colleagues
  • Develops and updates standard operating procedures as required

QUALIFICATIONS:

  • A bachelor’s degree in a scientific discipline and/or a healthcare professional (e.g., RN)
  • At least 4 years of experience in clinical project/study management within the pharmaceutical and/or biotech industry or at a CRO, preferably in neurosciences
  • A good understanding of all phases of the drug development process and the interdependencies between Clinical and other functional areas (e.g., CMC, nonclinical/toxicology, Regulatory Affairs etc.)
  • Demonstrated ability to successfully work across a variety of teams and manage multiple conflicting priorities
  • Demonstrated ability to successfully manage and complete clinical trials on time and within budget
  • Strong knowledge and understanding of ICH/GCP and US, Canadian and EU regulatory environments; previous experience with CTA and IND submissions preferred
  • A proven track record for problem solving and attention to detail
  • Excellent oral and written communication skills
  • Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team
  • Proficiency using Microsoft Project software an asset

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