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.
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
- 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
- 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
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.