Clinical Quality Assurance Auditor

Náplň práce, pravomoci a zodpovědnosti

TMQA, a clinical research Quality Assurance (QA) consultancy with offices in Edinburgh, UK and Bratislava, Slovakia, is looking for new colleagues to join their expanding team. We would like to hear from experienced clinical QA staff or clinical research staff (e.g. Senior CRAs) who would like to expand their careers into QA. This is an office-based position in Bratislava (TMQA Central Europe office) but home-based working in between site visits after the initial period of training will be considered. Please contact us at careers@tmqa.co.uk for more information or to submit your resume together with a cover letter explaining your reasons for applying.

Main Aims and Objectives:
The jobholder will be responsible for independent conduct of audits at locations around the world and provision of subject matter expertise in areas for which he/she has been trained and approved.

Key Responsibilities:
• Independent planning, conduct and reporting of audits and consultancies.
• Acting as a “Subject Matter Expert” in allocated areas of GCP and clinical trial conduct.
• Providing expertise in defined therapeutic areas.

Job Content:
• Performance of audits: planning, preparation, conduct, reporting, follow-up, closure, and peer review of audit reports.
• Professional expertise: maintaining and developing personal expertise in GCP through regular reviews of sources of information; assisting in the preparation and dissemination of GCP updates; organising/participating in internal professional development meetings.
• Consultancy and advice: assisting clients and TMQA/TMQA Central Europe staff in the analysis and improvement of clinical quality systems.
• Travel: arranging travel and accommodation for visits; maintaining records of expenses incurred (in line with Company policies); submitting expense claims accurately and timeously.
• Representing the Company: participating in or supporting business development activities (including visits to external (potential) clients and assisting with visits from (potential) clients); participating in external events (e.g. Research Quality Assurance (RQA) meetings); attending networking events.
• Conducting all activities in compliance with Company policies including: health and safety; security; confidentiality.

Jiné výhody

Competitive salary and benefits.

Minimální požadované vzdělání: University education (Master's degree)
Zaměření, obor: Life sciences
Pozici vyhovuje i uchazeč se vzděláním: Postgraduate (Doctorate)

Znalosti

• Language skills
  • English - Proficiency (C2)

Osobnostní předpoklady a dovednosti
Requirements:
Essential
• A degree in a relevant discipline (e.g. Life Sciences)
• Prior experience in clinical QA or monitoring/project management (e.g. as a Senior CRA)
• Excellent English language skills (verbal and written)
• Ability and willingness to travel
• Knowledge of standard office packages (Word and Excel)
• Knowledge of GCP regulations and guidelines
• Understanding of the clinical trial process

Essential (after training, where relevant)
• Good understanding of the audit process (planning, preparation, conduct and reporting)
• Basic understanding of other “GXP” standards as they impact on clinical research
• Membership of professional body (the RQA)

Desirable
• Understanding of additional office systems (Powerpoint and Access)
• Ability to make presentations
• Working knowledge of foreign languages (additional to English)

Práce v oboru: Zdravotnictví, farmacie, sociální péče, Bankovnictví, pojišťovnictví, finanční služby

Lokality: