Quality Manager for Clinical Operations

We are looking for Quality Manager in the field of Clinical Research Operations.
(Full time employment with working from home option)

You would provide quality oversight and monitoring of the processes in Clinical Operations, including:
- Revision of company operation documentations and policies; identification of conflicts between actual processes and written procedures and used standard forms, identification of areas for improvement of current processes
- Assessment of quality metrics, participation in CAPA development, development, and organization of trainings, etc.
- Oversight of staff qualification and performance in scope of assigned project(s)
- Quality oversight of project documentation, on-site activities, communication with project managers, project team, investigators, ...
- Quality control of reports, issue solving, follow-up and escalation process
- Contribution to internal and external audits and inspections
- Providing consultations and interpretations of regulations, guidelines; monitoring their updates and revisions and incorporating these into internal procedures.

Minimum qualification requirements:

- Bachelor’s degree required – preferred qualification in life sciences, medical sciences, or business degree; or the ability to prove comparable equivalent combination of education and experience in a related field.
- 5+ years in pharmaceutical or CRO industry
- Experience in active monitoring (CRA role) is preferred
- Profound knowledge of clinical research processes and medical terminology
- Expert knowledge of ICH GCP, and international and local regulatory requirements
- Passion for clinical research
- English language at C1 level of CEFR or higher
- Driving license B

Competitive salary
Flexible working hours and home-based working option
Great work-life balance
Performance and Retention Bonus
Career growth and development opportunities in a continuous learning culture
Friendly environment in a privately owned international company
Additional paid day off on your birthday
Fully paid meal vouchers
Other company benefits based on mutual agreement

*SanaClis is an equal opportunity and inclusive employer

Please, send your CV in English language.