PROJECT MANAGER (Real World Evidence & Late Phase)
Level will depend on experience
Job Purpose/Summary

Responsible for overseeing and coordinating operational aspects of projects according to contract ensuring quality, timeliness and client satisfaction and will manage all phases of client projects from planning to Completion.

What You?ll Do

• In conjunction with Directors and RWE Scientists, specific tasks or duties may include:
  • Planning: Creating timelines and project needs assessments
  • Coordinating: Organizing resources to develop the project, including multifunctional project team, budget, external vendors, etc.; managing timelines
  • Implementing: Producing or overseeing timely production of quality deliverable, on budget
  • Problem Solving: Creating effective solutions to challenges that arise during the project
  • Finalizing for Client / Senior Management: Oversight of final review and production of deliverables
• Conduct research to provide background or content to support development of client deliverables in conjunction with multi-disciplinary team.
• Oversee/coordinate operational aspects of RWE projects including but not limited to:
  • Synopsis and Protocol development
  • Feasibility assessments
  • Regulatory Submissions
  • Study Conduction, including recruitment, monitoring and data management
  • Study reporting (statistical analysis and study reports)
  • Scientific Writing
  • Gap Analysis
  • Systematic literature reviews and meta-analysis
  • Database analysis
  • Retrospective, cross-sectional and prospective observational program
  • Market access projects (Therapeutic and Economic reports)
  • Development of economic models and local customisation
  • Health Technology applications
  • Pricing and reimbursement strategy
  • Post-marketing authorization approvals consultancy activties
• Prepare or oversee production, review, and finalization of deliverable products for clients and senior management
• Provide project status reports to client and management
• Manage timelines and budgets, collaborating with finance and director to ensure project remains on time and in budget
• Conduct regular review of budget and timely identification of scope changes; communicate changes with internal team and client
• Training and utilization of various systems to support observational programs, including but not limited to CTMS, eTMF, data systems and any others requested by clients
• Utilizes Project Management tools in order to track and report on project progress / metrics; ensure timely entry of project information throughout the life of the project
• Assists with evaluating and managing project budget against project milestones in conjunction with Directors and takes corrective measure utilizing out of scope process
• Prioritize and manage resources to meet needs of multiple clients simultaneously
• Manage multifunctional teams with respect to coordinating timelines and communications with clients
• Assist in organizing and/or presenting at internal or external meetings
• Interact with multidisciplinary departments
• Serve as mentor to Project Coordinators, Research Associates (RAs)

What You Bring

• Base background / knowledge regarding medical terminology and drug nomenclature
• Strong organizational skills
• Ability to work independently and be self-motivated
• Excellent communication, organizational and record keeping skills
• Knowledge of Good Clinical Practice (GCP) / International Council for Harmonisation (ICH) guidelines and applicable regulatory requirements
• Proficient with computer technology, including Excel, PowerPoint, Endnote, Articulate, and Word
• Knowledge in Clinical Research
• Experience in Monitoring activities and study conduction
• BA, BS, MBA, or RN/BSN/MSN
• 3 years real world evidence, clinical or business background in drug or device research/development, biotechnology, pharmaceutical or clinical research and/or combination of education & experience
• Experience with real world evidence, drug development process and/or medical writing
• Credentialed project management training

Why CTI?

• We support career progression ? 25% of our global staff is promoted annually and we have a structured mentoring program to provide the support you need to move forward
• We value education and training ? We provide tuition reimbursement, partner with universities and colleges to create programs in our field, and have a dedicated training department
• We value our people - We have never had a layoff in our 20-year history, support a work-life balance with flexible schedules, and have provided cash bonuses every year for the past decade
• Our culture is unparalleled ? Click here to learn more about ?The CTI Way?
• We think globally and act locally ? We have a global philanthropic program supporting our team?s efforts to improve their local communities (Click here to learn more about our ?CTI Cares? program)
• We are looking toward the future ? We have had a consistent 15% growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average 95% annual retention rate
• Our work makes a difference ? We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market

After an appropriate period of training, we offer you an unlimited, varied and attractive job in an international company.