Senior CRA (m/f)

PPD is a leading global contract research organization (CRO) providing discovery, development and post-approval services as well as compound partnering programms. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. Currently, we are looking for an experienced CRA with fluent English to enlarge by one our qualified team based in Zagreb, Croatia. Description: You will be primarily tasked to set up and monitor clinical trials conducted in Croatia as part of international projects. You should thrive in multi-national project teams, be focused on delivering exemplary levels of customer service, as well as: - conduct site visits to determine protocol and regulatory compliance - provide overall management of clinical operations resources - be responsible for the operational oversight and support for clinical studies: ensure that studies are planned and conducted efficiently and effectively, track study process, identify solutions proactively - critically review feasibility assessments and provide expert advice and alternatives to ensure studies are planned realistically and within given timelines - drive compliance to requirements necessary for clinical team to consistently gain success on the assigned projects With a life sciences degree or nursing qualification and experience of Phase II to IV trials, you will have in depth knowledge of FDA and ICH GCP requirements.

Education and experience: - degree in Medical, Dental or Pharmaceutical Science - thorough working knowledge of drug development process, in particular monitoring and site management skills - extensive experience in clinical research industry including clinical monitoring Requirements: - in-depth knowledge of clinical development, Global Monitoring and Study Management processes, ICH-GCP, applicable legal and regulatory requirements - excellent organizational and negotiation skills - team player with the ability to work under own initiative - demonstrated skills to influence others and form strong cross-functional relationships - flexibility, proactiveness, critical assessment and good eye for detail - proven decision making skills - fluent English speaker - PC literate If you are attracted by this opportunity, please register your interest using the following link: http://www.ppdi.com/careers/, ref. No. 106 Only shortlisted candidates will be contacted. PPD Inc. is an equal opportunities employer.