Clinical Team Manager
Ergomed Plc
Kraków, Poland
6 d. temu

Company Description

Founded in 1997 by two Medical Doctors , Ergomed Plc is dedicated to the development of new drugs to save or improve lives.

Operating with a global footprint in over 55 countries, Ergomed has the expertise to manage even the most challenging clinical trials.

Ergomed provides services to over 100 clients in a range of therapy areas but excels in the provision of services for complex trials in Rare Diseases, Oncology and Neuroscience.

Job Description

  • Brief summary of Responsibilities :
  • The Clinical Team Manager will be responsible for operational project management and will act as the direct project line manager to allocated study Monitors.
  • The CTM proactively identifies, resolves / mitigates and escalates risks and / or issues to the PM / PD and Head of Clinical Operations as necessary
  • Direct communication with project allocated Monitors, Site Managers and CTAs
  • Direct communication and collaboration with the Sponsor representative in projects where only operational management is contracted, i.
  • e. if no project manager is assigned.

  • Verifying and ensuring that project team members (Monitors, Site Managers, CTAs) are trained (e.g. GCP, SOP, indication, protocol, study specific procedures / requirements, etc.
  • to perform their assignments

  • Organizing and facilitating Monitors’ Meetings throughout the project.
  • Organizing and facilitating project team meetings (e.g. weekly calls with Monitors, Site Managers, CTAs), and ensuring meeting minutes are reviewed, approved and distributed to all concerned parties
  • Developing, reviewing and revision of project documents (e.g. monitoring plan, CRF completion guidelines, study specific operating manual, study specific forms etc.)
  • Initiating corrective / preventative measures e.g. update of study guidance documents, performing re-training, performing co-monitoring, etc.
  • Investigator identification and selection,
  • Qualifications

  • Proven experience working within clinical operations
  • Ability to line manage study monitors / CRA’s
  • Experience of phase 2 / 3 trials ideally complex studies such as oncology or rare disease
  • Able to work in a fast paced small CRO environment and manage multiple projects
  • A minimum of a science based Bachelors degree
  • Able to work effectively with minimal supervision
  • Additional Information

    Why Should You Apply?

  • You want be involved in a wide range of interesting projects and studies
  • You want your achievements and hard work to be recognized
  • You want to work for a growing company where you can progress in your career and where there are opportunities for advancement.
  • You want to work in a company that has a great reputation with its clients and employees, and invests in its relationships with both.
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