Key Responsibilities:
- Manage SOPs, controlled documents, and Sponsor quality documentation within the QMS.
- Conduct compliance reviews of study documentation, systems, and training records.
- Provide GCP/GxP quality support and escalate compliance issues as needed.
- Support CAPA management, audits, inspections, and audit readiness activities.
- Perform vendor, site, and study audits, and manage supplier qualification processes.
- Support quality services, risk assessments, and maintenance of GCP/GxP and ISO-certified quality systems.
- Coordinate quality training and monitor quality metrics (KPIs/KQIs) to drive continuous improvement.
- Ensure timely completion of training, documentation, and administrative requirements.
- Perform additional quality and compliance-related duties as assigned.
Requirements:
- Bachelor’s degree, preferably in Life Sciences or a related scientific field.
- Strong English communication skills.
- Proficiency in Microsoft Office applications.
- Excellent planning, organizational, and time-management skills.
- Strong interpersonal skills with the ability to work collaboratively in a cross-functional team environment.
What we offer:
- Salary up to EUR 25,000/Anually
- Collaborative international environment
- Opportunity to work on impactful clinical research projects
- Professional growth and continuous learning
- Dynamic role combining technology and healthcare innovation
Who we are
OPIS is an International CRO with over 25 years of experience in conducting Phase I-IV, non-interventional and medical devices studies on an international level. We always offer state-of-the-art information technology solutions and innovative approaches to the increasing complexity and variety of projects.
OPIS extensive expertise covers all phases of drug-related trials, taking care of the Sponsor beyond the therapeutic area, offering also accurate clinical investigations for medical and diagnostic devices. With Global Clinical Research Locations all over the world, OPIS offers a full range of integrated clinical research services as scientific advice, medical writing, trial start-up, monitoring, study management, data management, statistics, pharmacovigilance, medical monitoring, electronic data capture as well as quality assurance and training.
Skills Required
- Bachelor's degree (preferably in Life Sciences or a related scientific field)
- Strong English communication skills
- Proficiency in Microsoft Office applications
- Excellent planning, organizational, and time-management skills
- Strong interpersonal skills and ability to work collaboratively in cross-functional teams
What We Do
OPIS was founded in 1998 by medical doctors from the Pharma Industry and is a Global clinical CRO with 25 years of experience in a wide range of therapeutic areas. OPIS provides full-service, 360° clinical trial support from study concept creation and protocol development to full project execution, study data handling and up to study closure, analysis, and reporting. We manage Phase I-IV, interventional, non-interventional and medical devices studies on an international level. In addition, OPIS also manages pre- and post-marketing clinical investigations for medical and diagnostic devices, nutraceutical, and food supplement studies. Our qualified, fully trained, and dedicated staff has managed 1470 studies to date. OPIS’s strength lies in its people and its specialized teams who assist clients from A-Z with medical writing, scientific and statistical consultancy for trial design and skilled teams of operational staff that ensure high quality project execution, with global coverage. Our mission is to increase the global development of safe and effective medical therapeutics through its high-science and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system... etc. OPIS is committed to continuous growth and expansion, while currently we have affiliates in 17 countries around the world. For more information, visit www.opisresearch.com
