Senior Site Specialist - German speaker

Senior Site Specialist - Sofia, Bulgaria - home or office based

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

We are currently seeking a Senior Site Specialist to join our diverse and dynamic team. As a Senior Site Specialist at ICON, you will be working within a large-scale, fast-paced environment, supporting the Study Start Up Team Lead in developing and executing the plan for country and site distribution. Your expertise and dedication will be essential in efficiently conducting SSU (Study Start Up) activities in the assigned countries, ensuring the smooth initiation and progress of clinical trials.

What you will be doing:

• Proficient knowledge of ICON SOPs/WPs, ICH/GCP and applicable country regulations/guidelines and ICON systems.
• Work with Site Partners and internal key stakeholders to optimize study performance and collaborate to drive successful site activation and project outcomes.
• Support the set up of internal tracking tools needed for site activation to enable effective tracking of progress according to site activation requirements.
• Serves as internal consultant to optimize site activation work and tool set up
• Act as primary point of contact on high volume studies or on study programs to coordinate the activities of Site Activation Specialists and to support execution of Site Activation to plan.
• Support training and onboarding of more junior Site activation specialists, if assigned on the same studies.
• Ensure accuracy and timely completeness of Trial Master File (TMF) documents submitted during start-up and perform a Quality Control (QC) review of files before transfer to maintenance for filing in TMF.
• Accurately forecast Site Activation plans and ensure they are reflected accurately in ICON’s systems, proactively follow through for achievement to plan.
• Contribute to effective site activation process and timelines: participate to internal study review meetings with study teams and support risk identification to site activation, mitigation and action planning.
• Proficiently drive Site activation duties per assigned studies and sites and that include:
  • To support Site Partners to proficiently collect, review, organize and assemble regulatory initial start-up and maintenance submission packages to Central EC/IRB, Local EC/IRB, Competent Authorities, any other local regulatory authorities as required by countries and in accordance with ICH/GCP and applicable country regulations/guidelines.
  • To support collection and assembling of all documents needed in the Critical Document Package (CDP) and of those required for site activation, ensuring that Sponsor and Investigator obligations are being met and are in compliance with applicable requirements and ICH/GCP guidelines.
  • To ensure accuracy and completeness of the Critical Document Package according to CDP checklists and timely update of the required tracking tools.
  • To support coordination of all necessary translations required for any start-up documentation.
  • To proficiently perform timely and accurate progress data entry of all documents collected from sites and relevant study site activation activities into the appropriate tracking systems and tools and oversee that the site activation tasks are executed according to site activation requirements.

Your Profile:

• A Bachelor's degree or local equivalent and/or appropriate experience from the Medical/science background and/or discipline.

• At least 3 years of experience or understanding of clinical study start-up requirements and activities, showing your expertise in the field.

• Fluency in the local language, English and German is essential, enabling you to effectively communicate and collaborate with international teams.

What ICON can offer you:

Visit our careers site to read more about the benefits ICON offers.

At ICON, inclusion & belonging are fundamental to our culture and values.   We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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.

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