Clinical Research Project Manager

October 13 2021
Industries Pharmaceutical, Biotechnology
Categories Project Management, Business Analysis, Pharma, Biotech, Sciences, R&D, Pharma, Biotech, R&D, Scientific, Research and development, Clinical research
Saskatoon, SK

The Vaccine and Infectious Disease Organization (VIDO) is Canada's Centre for Pandemic Research. Located at the University of Saskatchewan in Saskatoon, Canada, VIDO is a leader in human and animal infectious disease research and vaccine development. For over 45 years we have developed solutions to emerging diseases including eight commercially available vaccines—six of which were world's firsts, with four more in regulatory development.

As a National Centre, we are home to one of the largest and most advanced level 3 containment facilities capable of housing both small and large animals including rodents, poultry, pigs, cattle, and bison. We are currently expanding our specialized infrastructure to include a vaccine GMP manufacturing facility, a new multi-species level 2 animal facility, and upgraded capacity to include level 4 containment. Our vision includes the capacity to study any emerging disease in any animal model embracing a One Health approach to prevent emerging and re-emerging infectious disease of importance in human and veterinary health.

We are seeking a Clinical Research Project Manager to join out team. VIDO is developing multiple vaccines for use in both humans and animals. Many of these projects have reached or are about to reach the field testing/clinical stage of development. Reporting to the Associate Director of Vaccine Development, the Clinical Research Project Manager will be responsible for successfully managing and executing a variety of tasks associated with this stage of development that will enable these products to reach licensure.

Key Duties & Responsibilities

  • End-to-end management of field/clinical studies to ensure appropriate resourcing and timely, high-quality delivery. Ability to identify and organize resources and services needed to accomplish tasks, set objectives, plan for contingencies, and manage time effectively.
  •  Assist in screening, selection, and management of current and future CROs, vendors and field/clinical sites in accordance with contractual timelines, sponsor specifications, quality, budget, and GCP.
  • Develop and monitor study metrics to continuously assess study progress.
  • Act as the primary point of contact between VIDO and CROs, vendors, field/clinical team(s).
  • Monitor and track study status, timelines, and budget expenditures; identify opportunities and recommend implementation plans for efficiency measures.
  • Predict and resolve project issues and resource constraints with minimal assistance.
  •  Accountable for review of study budget, expense reports and financial records (invoicing/units/expenses) in conjunction with appropriate VIDO team members.
  •  Aid in the development and submission of regulatory applications.
  • Participate in study-specific regulatory audits.
  • Manage pre-clinical scientific projects from conception through execution, when needed, to ensure they are on time and on budget.
  • Participate in weekly project manager meetings ensuring clear, concise, and timely communication of project status, tasks, and actions.
  • Facilitate positive team member interactions.

Qualifications

  • The incumbent requires an undergraduate degree, preferably a BSc and Project Management Professional (PMP) certification, or equivalent experience. An advanced degree and/or equivalent clinical research experience is an asset.
  • Excellent knowledge of ICH/GCP.
  • 3+ years clinical research experience including project management and experience in clinical trial operations; or equivalent combination of education, training, and experience.
  • Experience working within and managing teams.
  • Experience in managing client relations.
  • Ability to work in a fast-paced environment.

Status: Permanent
Employment Group: Non-Union
Shift: Monday - Friday, 7.5 hours per day (37.5 hours per week)
Full Time Equivalent (FTE): 1.0

The successful applicant will be required to provide the following current verification(s) where 'Yes' is indicated below. Further information is available at: https://careers.usask.ca/tips-for-applying.php#Howtoapplyforaposition

Facility Access Screening including Criminal Record Check: Yes
Driver's License and Abstract Check: Not Applicable
Education/Credential Verification: Yes
Vulnerable Sector Check: Not Applicable

Interested candidates are asked to submit their application including a cover letter, CV, and the names of three references. Applications will be received until end of day October 28, 2021.

We thank all applicants for their interest, however only those selected for an interview will be contacted.

For more information visit: vido.org

Note: The University believes equity, diversity, and inclusion strengthen the community and enhance excellence, innovation and creativity. We are dedicated to recruiting individuals who will enrich our work and learning environments. All qualified candidates are encouraged to apply; however, in accordance with Canadian immigration requirements, Canadian citizens and permanent residents will be given priority. We are committed to providing accommodations to those with a disability or medical necessity. If you require an accommodation in order to participate in the recruitment process, please notify us and we will work together on the accommodation request. The University of Saskatchewan's main campus is situated on Treaty 6 Territory and the Homeland of the Métis. We pay our respects to the First Nations and Métis ancestors of this place and reaffirm our relationship with one another. Together, we are uplifting Indigenization to a place of prominence at the University of Saskatchewan.

Apply now!

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