CRA II or Senior CRA – Mid-Sized CRO – Poland
Upsilon Global have an exciting opportunity as a SCRA based within Poland.
One mid-sized CRO in which we have be partners for 5 years with, have plans to continue to expand at an exponential rate. Having already double in size in the last 3 years. They are looking for a highly motivated individual, who has early phase oncology experience.
Details are confidential, information available upon request. This US based CRO has expanded into Europe along with Australia/New Zealand, buying CROs within them regions to help growth. They specialise within Oncology, Haematology and Rare diseases. There main area of expertise is within oncology in which all managers within the CRO have mostly oncology backgrounds.
Max 2 protocols per CRA but can't offer regional travel, if asked. They will have the chance to learn regulatory aspect too, should they wish to do so also.
- To oversee and lead clinical operations.
- Ensuring regulations, SOPs and GCP guidelines followed.
- Managing budgets, deadlines, planning, resourcing and compliance.
- Being the first point of contact for both internal and external meetings.
- Maintaining the correct levels of resources.
- Interviewing clinical personnel to expand the team when necessary.
- Managing clinical and administrative personnel; this will include motivating, employing, training and assessing performances.
- Setting agreed project targets and overseeing the quality of deliverables from the Clinical Operations teams.
- Reporting KPIs to management and implementing solutions to meet targets.
- Assessing company policy and modifying solutions when necessary.
- Contributing to the development of clinical SOPs and department guidelines to meet regulatory, ethical and clinical standards.
- Supporting daily duties including: responding to inquiries from clinical sites, project members and client requests, project management, site monitoring and general clinical activities associated with a small team.
- Representing the Clinical Operations Department for proposals, budgets, P&L topics and contracts for the European markets.
Education and Qualifications
- Lifesciences related degree (BSc/MSc/PhD).
- Previous experience as a clinical research associate.
- Sound knowledge of ICH/GCP and regulatory requirements.
- Experience using clinical trial management systems.
For further information on this opportunity and to learn of similar positions, please contact Upsilon Global on +44. 20. 3. 8. 75. 99. 6. 6 or email ‘applications (at) upsilonglobal . com’.
My email: Louis.Peters@upsilonglobal.com