Country Site Activation Specialist

2 weeks ago

Belgrade, Central Serbia IQVIA Full time €40,000 - €60,000 per year

Job Overview:
Under moderate supervision, executes the feasibility, site identification regulatory, start-up, and maintenance activities in accordance with regulations, SOPs, and project requirements  at the regional, or country level.
Prepares and manages site documentation; reviews and negotiates site  documents and contracts with sites and sponsors; maintains, reviews, and reports on site performance metrics; serves as the primary point of contact for investigative sites; tracks completion of appropriate documents for sites; ensures contracts are fully executed; and establishes project timelines.  With moderate oversight and supervision, perform tasks at a country/region level associated with site activation activities in accordance with  applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May also include maintenance activities.

Essential Functions

• With moderate oversight and supervision, werve a Single Point of Contact (SPOC) to perform feasibility, site activation and some maintenance activities in assigned studies for investigative sites, according to applicable regulations, SOPs and work instructions, working closely with the  Site Activation Manager (SAM), Project Management team, and other departments as necessary. Review documents for completeness, consistency and accuracy, under guidance of senior staff.

• Prepare site documents, reviewing for completeness and accuracy.

• Inform team members of completion of regulatory contractual. and other documents for individual sites.

• Distribute completed documents to sites and internal project team members.

• Update and maintain internal systems, databases, tracking tools, timelines and project plans with accurate and complete project specific information.

• Review, track and follow up the progress, the approval and execution of required documents such as questionaires, CDAs, regulatory, ethics, Informed Consent Form (ICF) and Investigator Pack (IP) release documents. Requires advanced knowledge within a specific discipline typically gained through extensive work experience and/or education.

Qualifications

• Bachelor's degree in Medicine or Pharmacy (required).

• Other 1 - 3 years' clinical research or other relevant experience; or equivalent combination of education, training and experience.

• With 3 years' experience in a healthcare environment or equivalent combination of education, training and experience.


• Strong written and verbal communication skills, with good command of Serbian and English.


• Additional languages such as German, French, Italian, or Spanish are highly valued.

IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more

  • Senior Regulatory and Start Up Specialist

    2 weeks ago

    Belgrade, Central Serbia Precision for Medicine Full time €40,000 - €60,000 per year

    Precision for Medicine is not your typical CRO. At Precision for Medicine we have brought together new technologies, expertise and operational scale to help the life sciences improve the speed, cost and success rate of bringing life-changing therapies to patients. What sets us apart is the way we integrate clinical trial execution with deep scientific...

  • Study Start Up Specialist

    2 weeks ago

    Belgrade, Central Serbia ProPharma Full time €60,000 - €80,000 per year

    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the...

  • Senior Site Acquisition and Regulatory Specialist

    2 weeks ago

    Belgrade, Central Serbia CETIN Serbia Full time €40,000 - €50,000 per year

    About UsAs a leading telecommunications infrastructure provider in the region, CETIN drives digital transformation with a strong presence across Bulgaria, Hungary, Serbia, and Slovakia. Through our subsidiaries, we deliver advanced technology solutions that empower connectivity and enable innovation.CETIN owns and operates some of the largest...

  • Construction Site Engineer

    2 weeks ago

    New Belgrade, Central Serbia STRABAG Full time €60,000 - €80,000 per year

    ZadaciConstruction management and overseeing complete operations on projectsSite organisationCommunication with investors and supervisory authoritiesNegotiations with clients and subcontractorsCommunication with other sectors in the companyControl and organization of subcontactors' performanceCoordination of workers on the siteReport to superiors about all...

  • Employer Branding Specialist

    2 weeks ago

    Belgrade, Central Serbia Syneos Health Full time $80,000 - $120,000 per year

    DescriptionEmployer Branding SpecialistSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Every day we perform better because of how we work together, as one team, each...

  • Site Reliability Engineer

    2 weeks ago

    Belgrade, Central Serbia Camlin Group Full time €90,000 - €120,000 per year

    *About Camlin Group:*Camlin is a global technology leader that operates with the vision of bringing revolutionary products to life for a wide range of industries, including power and rail, and also has interests in a number of R&D projects in a variety of scientific sectors.At Camlin we believe in high quality engineering and design, allowing us to develop...

  • Architecture Specialist

    2 days ago

    Belgrade, Central Serbia CE GROUP DOO Full time €35,000 - €45,000 per year

    Company DescriptionCE GROUP DOO was founded in 2015 as a specialized company for technical consulting, design, and engineering services. CE GROUP DOO has developed a mode of work that is recognizable, reliable, and efficient, thanks to experience gained in both the global market and Serbia. Our mission is to build, contribute and improve the community.Role...

  • Specialist, Regulatory and PV Network

    2 weeks ago

    Belgrade, Central Serbia Ergomed Full time €40,000 - €60,000 per year

    The Specialist, Regulatory and PV Network is responsible for providing the strategy based on regulatory requirements and for completing regulatory and PV deliverables based on an established PV and regulatory plan. They also serve as a liaison between regulatory and other functional areas including external partners, clients, authorities and/or consultants...

  • HR Specialist with German

    1 week ago

    Belgrade, Central Serbia Syneos Health Full time €45,000 - €55,000 per year

    DescriptionHR Specialist with German ( 6 month Fixed Term)Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Every day we perform better because of how we work together,...

  • Chat support specialist

    2 weeks ago

    Belgrade, Central Serbia Workanova Full time €2,500 - €3,000 per year

    Chat Support Specialist – German Language (on-site) ABOUT THE COMPANY: WorkaNova is a global BPO customer experience specialist, providing exceptional customer care, sales, technical support, and back-office services. With clients across the Fintech, iGaming, and eCommerce industries, we operate in over 10 languages and are committed to delivering...