Job title       

 

Clinical Project Manager

 

Reports to

 

Project Director, Department of Project Management & Monitoring

 

Location

 

USA home based

 

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 the Sponsor/Ergomed SOP’s, ICH-GCP requirements and local regulations.

Candidates are required to have broad therapeutic experience and the ability to manage staff and projects.

 

Duties and responsibilities

  • Ensuring projects are delivered on time, within budget, within the agreed scope, maintaining the appropriate industry, Sponsor and Ergomed quality standards
  • Ensuring project team members are trained adequately and are confident in their conduct
  • Developing, reviewing and editing of project plans to assure consistency with project goals
  • Organisation and facilitation of project meetings related to study activities (study organisation, initiation, execution, closure)
  • Supervision of in-house filing of all clinical study related materials
  • Point of contact with Sponsor
  • Reporting the status of projects to the Sponsor and ERGOMED senior management
  • Serving as ERGOMED’s representative at different committee meetings (e.g. EC/IRB meetings)
  • Representing 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 study related training programs to enhance the knowledge of “good practice”, policies, ERGOMED SOPs and working procedures

 

Skills

  • Experience in managing all phases of clinical trials in a CRO environment
  • Experience in observational studies, neuroscience, women’s health or oncology is an advantage
  • Experience in managing complex studies
  • Experience in selecting and managing external service providers
  • Strong communication skills
  • Strong analytical and numerate skills
  • Minimum five years’ experience in the CRO industry
  • Ability to multi-task and organise work effectively
  • Ability to work effectively and deliver in a fast paced environment
  • Confidence with working independently and within a team

 

Qualifications

  • 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

 

If you are interested in this role or would like further information, please email us, ideally with your CV attached to: careers@ergomedplc.com