Senior Clinical Research Associate (m/f)
- OPTIMAPHARM d.d.
- Adresa: Almeria Business Tower, Ulica grada Vukovara 284, 10 000 Zagreb
- Web: http://www.optimapharm.hr
OPTIMAPHARM is a European CRO (Contract Research Organization) that provides flexible, high standard and client focused clinical research services to pharmaceutical, biotechnology and medical device companies across Europe. OPTIMAPHARM is a service company with confidence, quality, expertise, integrity, intelligence and flexibility as guiding principles in development of innovative life science products.
OPTIMAPHARM has been operational since 2006 with headquarters based in Zagreb (Croatia) and regional offices based in Belgrade, Sarajevo, Skopje, Prague, Ljubljana and Antwerp. OPTIMAPHARM offers a full range of CRO services in Europe and in the ascending market of South-Eastern Europe (SEE) with geographical coverage in 11 countries (Croatia, Slovenia, Serbia, Bosnia & Herzegovina, FYR Macedonia, Montenegro, Czech Republic, Slovakia, Belgium, Netherlands and Luxemburg). OPTIMAPHARM is a joint stock company owned by the management.
OPTIMAPHARM's mission is to provide the flexible, high standard and client focused services to pharmaceutical, biotechnology and medical devices companies in order to develop better medicines for people.
We have on board the most experienced team of clinical research professionals in the region. OPTIMAPHARM is currently undergoing strong growth in number of projects in Croatia and surrounding countries and therefore looking to increase its Clinical Operations Team.
The Senior Clinical Research Associate (sCRA) is a member of the clinical development team who is responsible for all aspects of study site monitoring to ensure that the rights and well-being of human subjects are protected; the reported trial data are accurate, complete and verifiable from source documents, and that the conduct of the trial is in accordance with the currently approved protocol/amendment(s), relevant study specific documentation, Standard Operating Procedures, ICH GCP Guidelines and applicable regulatory requirements. In doing this, the Senior Clinical Research Associate represents Company and the Client/ Sponsor to site personnel and colleagues with professionalism and integrity.
- University degree, preferably in medical or life sciences.
- Individuals with university degree in biotechnical, technical, bio medicinal, social or humanistic sciences must have nursing education or other relevant healthcare college degree
Experience and knowledge:
- Candidates should have at least 4 (four) years of clinical trial monitoring experience
- High level of knowledge of ICH GCP Guidelines, knowledge of regulatory requirements and a strong interest in clinical research
- Excellent understanding of clinical trial process
- Experience in Quality Systems and audit/inspection visits
- Fluent in local language and in English, both, written and verbal
- Computer proficiency is mandatory
Skills and personality:
- Ability to read, analyze, and interpret common scientific and technical journals
- Excellent verbal and written communication skills
- Very good interpersonal and negotiation skills
- Ability to work with minimal supervision
- Affinity to work effectively and efficiently in a matrix environment
- Excellent numerical skills and reasoning ability
- A current, valid driver’s license would be advantageous (position requires up to 30% of travel)
Looking forward to receiving your CV in Croatian and English.
Please send your application till 27 March 2017 the latest. Please note that only shortlisted candidates that meet the requirements will be contacted for further selection process.
Visoka stručna sprema, Magistar struke
Potrebne godine iskustva:
Engleski (napredno), Hrvatski (napredno)
- By joining our fast growing and prosperous Clinical Operations team, you will have a great opportunity for further personal growth and career development
- We offer opportunity to work on the international projects and to be member of international clinical research teams, competitive compensation and benefits package, a lot of training opportunities and flexible working hours
Stalni radni odnos