Ref #: 31265

Employment type: Permanent - Full-Time

Location: Bulgaria

Posted: 06-Aug-2021


ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.
With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.
Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Role:
• Act as primary company contact for assigned trial at the country level,
• Drive study compliance by maintaining and updating trial management systems, using study tools and management reports available to analyze trial progress.
• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Delivers competent vendor management at the country level to support the study and may submit requests for vendor services and support vendor selection. This includes reviewing and approving site and local vendor invoices as required. As required, manages the local study supply.
• Ensures high standards for study monitoring by conducting quality local trial team meetings and facilitating SM training, when needed
• Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting timelines and documented
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to expectations (metrics) and archiving retention requirements.
• With focus on quality, will work closely with CRAs to ensure CAPA is implemented for audits/inspections or any quality related visits. May conduct accompanied site visits with CRAs, if delegated by CRM.
• Ensure accurate finance reporting and trial delivered within budget. Forecasting and proactive management of country/local trial budget. If applicable, may assist in negotiation of trial site contracts and budgets.
• Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA approvals,
• Participation in site feasibility ensuring consistent conduct of pre‐trial assessment visits and appropriate follow‐up of pre‐trial visit report and country feasibility report

To be successful in the role, you will have:
• BA/BS degree.
• Degree in a health or science related field.
• 2 years of local trial management experience.
• Strong working knowledge of ICH‐GCP, local laws and regulations
• Proficient in speaking and writing the country language and English.

Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know.