Clinical Project Manager (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 Clinical Project Manager (CPM) is a member of the clinical development team that is primarily responsible for the setting up and management of a clinical project according to the protocol and relevant project plans, current ICH GCP guidelines, applicable Standard Operating Procedures, relevant laws and regulations and signed contract between OPTIMAPHARM and Client/ Sponsor.
The Clinical Project Manager is responsible to ensure that the activities which have been contracted to OPTIMAPHARM are coordinated effectively that would ensure that the project is delivered to the Client/ Sponsor on time and within the budget
- 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:
- Minimum of 1 year of project management experience is a requirement without exception
- Minimum of 5 years of clinical research experience
- Extensive experience in advanced monitoring of the clinical trials
- Excellent knowledge of ICH GCP Guidelines
- Excellent knowledge of regulatory requirements
- Experience in Quality Systems and audit/inspection visits
- Computer proficiency is mandatory
- Fluent in local language and in English, both, written and verbal
Skills and personality:
- Strong problem-solving and leadership skills
- Ability to read, analyze, and interpret common scientific and technical journals
- Excellent verbal and written communication skills
- Ability for management of multiple functions of trial team and in dealing with multiple investigators and cultures
- Excellent numerical skills and reasoning ability
- Excellent organizational and planning skills
- Ability to define problems, collect data, establish facts, and draw valid conclusions
- 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