Job Purpose

The Ergomed Project Manager will be responsible for managing clinical trials in the CRO environment, to supervise, co-ordinate and lead clinical trial specific activities in accordance with Sponsor/Ergomed SOP’s, ICH-GCP requirements and local regulations. Candidates need to have broad therapeutic experience and the ability to manage staff and projects.

Reports to

Project Director, Department of Project Management & Monitoring

Duties and Responsibilities

  • Ensure the projects are delivered on time, within budget, and agreed scope, maintaining the appropriate industry, Sponsor and Ergomed quality standards
  • Ensure project team members are trained adequately and are confident with their conduct
  • Develop, review and edit of project plans to assure consistency with project goals
  • Organisation and facilitation of project meetings related to study activities (study organization, initiation, execution, closure)
  • Supervision of in-house filing of all clinical study related materials
  • Point of contact with Sponsor
  • Reporting status of the projects to Sponsor and ERGOMED Senior Management
  • Serves as ERGOMED representative on different committee meetings (e.g. EC/IRB meetings)
  • Represents ERGOMED at external meetings, providing liaison with scientific/medical experts in other CRO/Sponsor companies
  • Developing, reviewing and editing of relevant SOPs to assure consistency with “Good practices” and other regulatory standards/requirements
  • Developing of study related training programs to enhance knowledge of “Good practice”, policies, ERGOMED SOP’s and Working procedures

Skills

  • Experience of managing all phases of clinical trials in a CRO environment
  • Experience in observational studies, neuroscience, women’s health or oncology is of an advantage.
  • Experience in managing complex studies
  • Experience in selecting and managing external service providers
  • Strong communication skills
  • Strong analytical and numerate skills
  • Minimum 5 years’ experience in CRO Industry.
  • Ability to multi task and organize work effectively
  • Ability to work effectively and deliver in a fast paced environment.
  • Confident to work both independently and within a team

Qualification

  • Bachelor of Science degree or equivalent University education/degree in Life Sciences or Healthcare
  • Proficiency in English – both written and spoken, second language preferred.
  • Start date: asap

Location

Office based in Boston, USA  Krakow, Poland; Guildford, UK; Zagreb, Croatia or Belgrade, Serbia.  We would also consider remote (home based) applicants in any of these countries, for those with extensive experience.