Clinical Project Director

1 day ago


Ottawa, Ontario, Canada Caidya Full time

Job Overview

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The Clinical Project Manager at Caidya plays a pivotal role in ensuring the timely delivery of project objectives and timelines. This position is responsible for managing clinical trials, adhering to project Standard Operating Procedures (SOPs), Good Clinical Practice (GCP)/ International Conference on Harmonization (ICH) guidelines, and other applicable regulations.

Key Responsibilities:

  • Develop a clear and measurable project management plan in conjunction with the Director, Clinical Operations – Project Management and Sponsor representative(s).
  • Manage clinical projects, including deliverables from all functional areas and vendors, within contractual timelines, sponsor specifications, quality, and GCP.
  • Define project scope, timelines, milestones, and work limitations for project staff.
  • Establish project metrics and report schedules with client representatives, providing at least monthly project updates.
  • Serve as the primary liaison between the project team and the sponsor/customers and service providers.
  • Identify critical project success factors for tracking, analysis, and reporting, including probability and impact of potential project risks.
  • Ensure adherence to project budget and contracts and assist in identifying and developing scope change documents.
  • Monitor project status, budget expenditures, and identify problems, recommending solutions.
  • Coordinate resource allocation for project conduct and completion with functional area leaders, ensuring appropriate staffing to accomplish project goals within budget.
  • Develop budget review strategies, create scope definition documents, and implement proactive cost containment strategies, communicating with project teams.
  • Identify out-of-scope work and initiate the scope change process with sponsor representatives.
  • Oversee site contract and budget negotiation processes, completing them in accordance with project timelines and cost parameters.
  • Responsible for reviewing and approving project grants, expense reports, and financial records (invoicing/units/expenses) in conjunction with project team members.
  • Accountable for developing, overseeing, and delivering project team training.
  • Determine required project processes, train, and maintain project team knowledge/application of project processes.
  • Establish and communicate team performance expectations and guidelines.
  • Manage the performance of all service providers, delegating assignments to encourage growth, development, and responsibility.
  • Provide performance evaluation input for Caidya project team members and service providers.
  • Participate in developing and reviewing departmental SOPs, guidelines, and intradepartmental procedures, as well as continuous process improvements programs, as assigned.
  • Collaborate with the Director, Clinical Operations, Project Management, and Directors, Business Development in the development/presentation of Caidya capabilities/proposal defenses.
  • Support proposal development by participating as requested, representing Caidya Project Management at professional, marketing, and new business meetings.

Requirements:

Education:

  • Bachelor's degree preferred; Advanced degree preferred or equivalent clinical research experience.

Experience:

  • Minimum of 2+ years of experience managing clinical trials as a Clinical PM or similar title and level of responsibilities at a Contract Research Organization (CRO) is required.
  • 5+ years of experience in the clinical research industry.

Estimated Salary: $85,000 - $110,000 per annum, depending on experience.

Location: Remote – United States or Canada

Company Overview:

Caidya is a leading Contract Research Organization (CRO) providing comprehensive clinical trial management services. Our team of experts is dedicated to delivering high-quality results while ensuring regulatory compliance and operational efficiency.



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