Regulatory and Start up Manager - based in Turkey (R1085530) in Istanbul, Turkey at IQVIA™

Date Posted: 7/4/2019

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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.

As a Regulatory and Start-up Manager with IQVIA Clinical Research team, you’ll be responsible for Site Start-up process and Ministry of Health relationship management.

  • Interface with internal contacts to determine operational strategy and expectations and parameters for the review and negotiation of contracts and regulatory documents.
  • Provide Proposal Management with input on proposals and budget development for SSU components of projects.  Attend proposal defenses as needed.  Create Investigator Grant Estimates for Proposal Management, as necessary.
  • Work with sponsors and internal team members to establish regulatory requirements and contracts necessary for SSU components of projects.  Review and negotiate regulatory documents, contracts, and contract amendments with sponsors for agreement on wording and budgets.  Ensure accuracy and completeness of documents.
  • Where applicable, review and ensure project work instructions for SSU projects are completed and accurate.  Provide feedback to SSU leads in the writing of project work instructions.
  • Resource staff efficiently to ensure achievement of utilization and SSU realization targets.
  • Interact with Clinical Operations, Project Management and Site Identification on SSU project specific status and deliverables.
  • Review and analyze site performance metrics and processes to provide input in the development and implementation of process/system improvements.
  • Accountable for staff efficiency and adherence to standard operating procedures (SOPs), work instructions, and project instructions and timelines.
  • Identify and make recommendations to resolve ongoing training and development needs of staff.
  • Manage staff in accordance with organization’s policies and applicable laws.  Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems.  Approve actions for all management / human resource matters.
  • Mentor SSU Leads and ensure adherence to start-up project timelines, scope of work and budget.
  • Serve as SSU Lead for single projects or programs as necessary.
  • Serve as SSU advisor for designated clients as necessary.
  • May manage site identification activities.

All applications will be treated with strict confidentiality

Candidates interested in joining  Clinical Research department as a Regulatory and Start-up Manager should have:

  • Bachelor's degree in life sciences or related field.
  • At least 5 years in clinical research industry, including experience in people management.
  • Client Facing skills and ability to develop regulatory authority, and institution relationship.
  • Deep understanding of regulated clinical trial environment, specifically regulatory and site start-up activities.
  • Excellent communication skills (written and verbal) including good  presentations skills, business acumen and reporting,
  • Fluent in English language (written and verbal), additional languages will be highly valorated,
  • Demonstrable analytical, and problem-solving skills,
  • Good leadership skills, with ability to motivate, coach and mentor
  • Good organizational and planning skills

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: R1085530


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