Senior Project Manager

ErgomedRaleigh, NC

About The Position

Ergomed is a specialist clinical research organization focused on rare disease and select oncology indications. We focus on the most complex trials, the studies where experience, judgement, and rigorous operational accountability make the biggest difference. We partner with small to midsize biotech companies to move promising therapies through early phase development, so they reach the patients sooner. We choose complex work on purpose. Rare disease and oncology trials carry real operational risk, and our people are experts at reducing it, protecting timelines, data quality and the experience of sites and patients at the same time. It is demanding, meaningful work, and no one here forgets that patients cannot wait. That is why culture matters to us as much as capability. We have built a collaborative, international team where people share ideas, grow their careers and are trusted to take ownership early. With colleagues across North America, South America, Europe, Asia and Australia, we value teamwork, flexibility and a real commitment to work-life balance, because good science comes from people who feel supported. If you want work with purpose, the agility to make an impact and a team that cares about the people behind the work as much as the work itself, we would love to hear from you.

Requirements

  • Experience serving as a Project Manager of international clinical trials in a CRO environment
  • Knowledge of Oncology and Rare Disease therapeutic areas
  • Experience in selecting and managing external service providers
  • Strong analytical, organizational and communication skills
  • Bachelor’s Degree in a science related discipline.

Responsibilities

  • Ensure that projects are delivered on time, within budget, and agreed scope, maintaining the appropriate industry, sponsor and Ergomed quality standards
  • Liaise with project team members, provide training where needed and ensure correct allocation to tasks
  • Develop, review and edit project plans to assure consistency with goals and milestones
  • Organization and facilitation of project meetings related to study activities (study organization, initiation, execution, closure)
  • Serve as primary point of contact with sponsor and Ergomed Senior Management on project status
  • Represent Ergomed at external meetings, providing liaison with scientific/medical experts in other CRO/Sponsor companies and for committee meetings, (e.g.EC/IRB)
  • Develop review and edit of relevant SOPs to assure consistency with Regulatory standards and develop study related training programs to support this.
  • Contribute to bid defense activities
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