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Quality Manager for Clinical Operations

SanaClis s.r.o.

Information about the position

  • Place of work: Bratislava
  • Basic wage component (gross) and other rewards: 2 000 EUR/monthnote - final salary will be based on mutual agreement and will reflect the seniority level of an applicant
  • Contract type: full-time

Job description, responsibilities and duties

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

Employee perks, benefits

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

Information about the selection process

Please, send your CV in English language.

Requirements for the employee

Candidates with education suit the position

University education (Bachelor's degree)
University education (Master's degree)
Postgraduate (Doctorate)

Educational Specialization

life sciences

Language skills

English - Advanced (C1)

Other knowledge

common computer literacy - Skillful

Driving licence

B

Experience in the position/sector

Clinical Operations, CRO or Pharmaceutical industry

Number of years of experience

5

Advertiser

Brief description of the company

SanaClis is a full-service European CRO offering a comprehensive range of services for clinical trials. In additional to being a full-service CRO, SanaClis is one from very few CROs in the world who has in-house logistics capabilities. This includes QP services, customs brokerage, warehousing and distribution, and sourcing of clinical trial materials, comparators and rescue medication.

Number of employees

200-249 employees