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Clinical Project Manager / Sponsor Oversight, US (Contractor)

Huma

Huma

Operations
United States · Remote
Posted on Wednesday, April 19, 2023
Giving the world more time.
For the first time in human history we have the technology, data, and insights to redefine health. Together with our partners, we will make the leap from reactive to proactive medicine. By collectively benefiting from the data we individually generate, we can all live our longest, fullest lives. Huma partners with scientists, technologists, healthcare, and life sciences professionals to understand, treat, and ultimately prevent ill health. Giving knowledge and power to those with medical conditions, while saving clinicians time, energy, and valuable resources.
We are looking for an experienced Clinical Project Manager. As a Project Manager in the Clinical Operations team you will be responsible for clinical trials, non-interventional studies and medical device studies of high complexity.

Your mission

  • Collaboration, management and supervision ("Sponsor Oversight") of CRO/vendor services in the conduct of clinical trials in accordance with ICH-GCP and local lawsRisk management
  • Preparation and maintenance of Sponsor Oversight documentationConclusion of subject/study insurance
  • Preparation of and participation in co-monitorings, audits and inspections, preparation of an action plan for follow-up of audit and inspection findings
  • Preparation and further development of standard operating procedures (SOPs) in the area of clinical research/sponsor oversight, including the development and implementation of key performance indicators (KPI) for measuring and evaluating services
  • Representation of the overall project to the Steering Committee and other stakeholders
  • Organisation and implementation of investigator meetings and data safety monitoring board meetings.
  • Primary contact of clients in the US
  • Managing local study sites (e.g. supporting contracting, remuneration processes, general site support)
  • Conducting regulatory submissions in the US
  • Coordination of US based CRAs
  • Conducting monitoring visits as needed at the East Coast

From day one in this role we’ll expect you to have

  • A Bachelor’s degree or post graduate diploma ,successfully completing scientific studies or a comparable suitable qualification, ideally with a medical focus
  • You have already gained professional experience within the industry, e.g. CRO, pharma or biotech (at least 5 years experience in clinical research/monitoring or project management)
  • Knowledge of GCP/ICH, ISO 14155 as well as ISO 20916 and AMG/MDR/IVDR is desirable.
  • Experience as Clinical Project Manager (in the pharma/biotech or CRO industry) in planning, organising, monitoring, conducting and evaluating clinical trials according to ICH-GCP and other (inter)national regulations.
  • Experience with all aspects of vendor management and sponsor oversight: from contract development to performance management.
  • You have an analytical, solution-oriented and responsible way of working
  • You enjoy working with electronic data and databases and have good knowledge of Office applications
  • You have a high level of social competence and the ability to work in a team
  • You proactively contribute to the company and want to make a significant contribution to the success of the company.

It’s great, but not required, if you have

  • Start-up experience

You will thrive at Huma if you are

  • A Self-solver - you are resourceful and seek solutions through collaboration
  • Resilient - show adaptability, be a pro-juggler and have the ability to move fast
  • A Visionary - imagine what is possible and have the courage to take risks that will drive our business forward
  • An Ambassador – you are professional, polished, and a product expert
  • A Driver of results - always thinking, quantifying, comparing and coming up with ways to make Huma better

What we can offer you

  • Home office allowance to support home working
  • New Apple equipment
  • Family first culture - giving the flexibility you need
  • A team of smart, like-minded, creative professionals who will constantly support and challenge you to build better solutions every day
  • The opportunity to work with some of the most interesting and exciting companies in the world.
Come join us!
We believe magic happens when you bring together diverse ideas, experiences, and styles. We want to create a world where people live longer, fuller lives, and to do that well we need a team that represents all of the people and communities who use our solutions. We aspire to create an environment where everyone has the opportunity to do their best work. We are always looking for ways to improve so if you have any suggestions, please get in touch.
Dear recruitment agency friends: Huma attracts an amazing number of direct candidates and we do not need any help at this stage, so please do not send us unsolicited agency resumes. This is not a great use of your time, and we will not accept any liability or fees for any resumes or candidates which we have not asked you to find for us.