Regulatory Start-Up Coordinator/Specialist with English and Italian language
IQVIA
Athens, GR
πριν από 1 μέρα
source : DirectEmployers Association

IQVIA™ is the leading human data science company focused on helping healthcare clients find unparalleled insights and better solutions for patients.

Formed through the merger of IMS Health and Quintiles, IQVIA offers a broad range of solutions that harness the power of healthcare data, domain expertise, transformative technology, and advanced analytics to drive healthcare forward.

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.

Review, prepare and negotiate site contracts and budgets with sites, if applicable. 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. May perform Site Selection Visits if a trained monitor. May participate in feasibility and / or site identification activities.

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES In-depth knowledge of clinical systems, procedures, and corporate standards. 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. Join Us Making a positive impact on human health takes insight, curiosity, and intellectual courage.

    It takes brave minds, pushing the boundaries to transform healthcare. Regardless of your role, you will have the opportunity to play an important part in helping our clients drive healthcare forward and ultimately improve outcomes for patients.

    Forge a career with greater purpose, make an impact, and never stop learning. At IQVIA, we have a vision. Where every healthcare decision is based on evidence.

    Where data science and human science come together to improve global health. Where new and creative solutions aren't just possible - they are expected.

    Thank you for your interest in growing your career with us. It takes insight, curiosity, and intellectual courage to transform healthcare.

    The 56,000+ employees of the IQVIA family of companies, including Q2 Solutions, are reimagining a world without the consequences of disease.

    We are brave minds bringing powerful ideas to reality. At IQVIA, you can truly make an impact in an environment where you're supported to succeed.

    EEO Minorities / Females / Protected Veterans / Disabled

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