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04.02.2019, Ref.#: 1807304
Regulatory & Start Up Specialist with English and Bulgarian language, IQVIA RDS Bulgaria EOOD
Месторабота София; Постоянна работа; Пълно работно време
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Regulatory & Start Up Specialist with English and Bulgarian language
PURPOSE
Perform tasks at country level associated with Regulatory, Start-up (RSU) and Maintenance activities in accordance with
applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and
contractual/budgetary guidelines. May participate in feasibility and/or site identification activities.


RESPONSIBILITIES
•Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, RSU
•Team Lead, Clinical Operations, Feasibility, Site Identification, Project Leadership and GICS.
•Ensure adherence to standard operating procedures (SOPs), work instructions (WIs), quality of designated deliverables and to project timelines.
•Perform Regulatory, Start-up and Maintenance activities according to applicable regulations, SOPs and work instructions.
•Distribute completed documents to sites and internal project team members.
•Prepare site regulatory documents, reviewing for completeness and accuracy.
•Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
•Review and provide feedback to management on site performance metrics.
•Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
•Inform team members of completion of regulatory and contractual documents for individual sites.
•Review, track and follow up the progress, the approval and execution of documents, including contracts, regulatory, ethics, ICF and IP Release documents, in line with project timelines.
•Provide local expertise to RSU leads and Project team during initial and on-going project timelines planning.
•Perform quality control of documents provided by sites.
•May have direct contact with sponsors on specific initiatives.



REQUIRED KNOWLEDGE, SKILLS AND ABILITIES

In-depth knowledge of clinical systems, procedures, and corporate standards.
•Fluent in English and Bulgarian, additional language is an asset
•Effective communication, organizational, planning and interpersonal skills.
•Ability to work independently and to effectively prioritize tasks.
•Ability to work on multiple projects.
•Knowledge and ability to apply GCP/ICH and applicable regulatory guidelines.
•Knowledge of applicable regulatory requirements, including local regulations, SOPs and company’s Corporate Standards.
•Understanding of regulated clinical trial environment and knowledge of drug development process.
•Ability to establish and maintain effective working relationships with coworkers, managers and clients.

MINIMUM REQUIRED EDUCATION AND EXPERIENCE
Bachelor’s Degree in life sciences or a related field and 1 year‘s clinical research or other relevant experience; or equivalent combination of education, training and experience.


PHYSICAL REQUIREMENTS
Extensive use of keyboard requiring repetitive motion of fingers.
Extensive use of telephone and face-to-face communication requiring accurate perception of speech.
Regular sitting for extended periods of time.


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