* Proactively engage in both quality assurance and risk management activities to ensure project deliverables are met. Initiate improvements to enhance the efficiency and the quality of the start-up work performed on assigned projects
* Track project progress against financial milestones using applicable financial systems
* Ensure effective cross-functional teamwork among project team members including both internal and external ancillary services
* Develop a site activation and maintenance strategy in conjunction with the Project Lead, other functional groups and the client to ensure start-up and maintenance deliverables are completed within agreed project timelines and in accordance with client’s expectations
* Create or review required project start-up plans. Distribute, implement and monitor compliance to project plans and revise as necessary. Review Client vs CRO responsibilities related to start-up
* Understand client expectations for deliverables/milestones and liaise with applicable functional teams in creation and modification of site activation timelines throughout the lifecycle of the project
* Prepare and present as operational lead in internal Project Review meetings
University/college degree (life science preferred) or certification in a related allied health profession (i.e. nursing, medical or laboratory technology) from an appropriately accredited institution. In lieu of the above requirement, candidates with five (5) or more years of relevant clinical research experience in pharmaceutical, CRO industries or experience in a health care setting will be considered.
Five (5) or more years of drug development and clinical research experience (pharmaceutical, biotech or CRO), preferably including two (2) or more years project management responsibility / leading clinical trials in Study Start-up.
Experience in managing projects in a virtual environment.
Demonstrated ability to handle multiple competing priorities and to utilize resources effectively.
Financial awareness and ability to actively utilize financial tracking systems.
Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system.
Demonstrated ability to lead by example and to encourage team members to seek solutions independently.
Excellent communication, planning and organizational skills.
Ability to review/analyze and report relevant data and interpret protocols and regulatory documents.
Ability to work independently.
Ability to negotiate and liaise with clients in a professional manner.
Ability to present to staff at all levels.
Strong computer skills with an ability to understand, access and leverage technology alternatives.
A working knowledge of ICH GCP, US FDA regulations, regulations applicable to local office, guidelines, and practices regarding Good Clinical Practices.
Detailed knowledge of financial control procedures (i.e. costing systems, time reporting).
Working knowledge of project management processes, especially concerning study start-up.
Working knowledge of time and cost estimate development.
Broad knowledge of drug development process and client needs.
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