Manager, Reguratory & Startup (R1117695) in Seoul,SK at IQVIA™

Date Posted: 2/6/2020

Job Snapshot

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Job Description

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.

Essential Functions

  • Specific responsibilities may vary across individual positions. Typical responsibilities of this job classification include the following:
  • Serve as SSU lead within region for project(s) or programs or service line. Lead SSU team or service line in all the activities.
  • Monitor team efficiency and adherence to project timelines, budget and SOPs and WIs.
  • Maintain and manage SSU data tracking entries in database. Review for completeness and accuracy.
  • Review and provide feedback to management on site performance metrics.
  • Work with sponsors and internal team members to establish regulatory requirements and contracts necessary for start up.
  • Review and negotiate regulatory documents and contracts with sites and sponsors for agreement on wording and budgets.
  • Serve as central contact for investigative sites, designated project reports, and customer service.
  • Resolve site issues and determine status for product shipment.
  • Work with regulatory team members or sponsor to secure authorization of regulatory documents.
  • • Work with legal team members or sponsor to secure authorization of contracts.
  •  Work with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.
  •  Where applicable, provide work instructions to team members in preparation of regulatory submissions.
  •  Facilitate process improvement efforts both within the department and in cooperation with other departments.
  •  May be assigned as ad hoc member to various process improvement working groups.
  •  Participate in sales presentation and proposal development; may provide input into budget development.
  •  Participate in mentorship and training of less experienced staff.
  •  May be assigned contract review responsibilities.
  •  May represent department at internal and external presentations including sponsor audits.
  •  May translate or review completed translations of critical documents.
  •  May participate in feasibility and/or site identification activities.

Additional Work Experience

  • 5 years clinical research experience, including 1 year experience in a leadership capacity
  • Equivalent combination of education, training and experience

Skills and Abilities

  • In-depth knowledge of clinical systems, procedures, and corporate standards
  • Strong knowledge of medical terminology and regulations
  • Broad knowledge of clinical research
  • Strong knowledge of Microsoft Office and e-mail applications
  • Effective communication, organizational, and interpersonal skills
  • Effective presentation skills
  • Effective leadership skills
  • Ability to work independently and to effectively prioritize tasks
  • Ability to delegate
  • Ability to manage multiple projects
  • Attention to detail
  • Ability to establish and maintain effective working
  • relationships with coworkers, managers and clients

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.

Job ID: R1117695


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