Regulatory & Start Up Specialist

  • Company:
    IQVIA
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    6 hours ago
  • Category:
    General

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.

+ **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, 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.

+ Perform quality control of documents provided by sites. **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 experience working in regulatory and/or start-up departments.

+ Intermediate English level

+ External Job DescriptionExternal Job Description **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, 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.

+ Perform quality control of documents provided by sites. **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 experience working in regulatory and/or start-up departments.

+ Intermediate English level

_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.

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