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Clinical Trial Manager - IQVIA Biotech

Clinical Trial Manager - IQVIA Biotech

IQVIARoodepoort, Gauteng, South Africa
13 days ago
Job description

Job Overview

Clinical Trial Manager - IQVIA Biotech

Clinical Trial Managers are an integral part of clinical trial delivery, leading and working alongside clinical teams to improve patients’ lives by bringing new drugs to the market faster. The Clinical Lead is a member of the core project team responsible for clinical delivery of full service, large, multi-regional studies to meet contractual requirements and in accordance with SOPs, policies and practices.

Oncology experience required

Essential Functions

  • Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP, protocol), customer requirements (contract), and internal requirements (policies, SOPs, project plans).
  • Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place.
  • Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle.
  • Ensure clinical quality delivery by identifying quality standards / requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
  • Manage clinical aspects of project finances including Estimate at Completion (EAC). Understand the scope of clinical delivery and create plans to deliver. Monitor and manage changes against baseline EAC and identify additional service opportunities or out of scope work.
  • Work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
  • Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
  • Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
  • Resourcing and Talent Planning of the clinical team. Manage the clinical team at project level to successfully deliver the project through the establishment of high-quality operational plans and guidance and project related trainings.
  • Conduct regular team meetings and communicate appropriately to achieve objectives.
  • Support professional development by providing feedback to clinical team line managers on performance relative to project tasks to support professional development.
  • Adopt corporate initiatives and changes and serve as a change advocate when necessary.
  • May contribute to the development of the clinical delivery strategy for business proposals. Participate in bid defense preparations and meetings. Develop and present Clinical Operation plan in partnership with Business Development and Project Leadership.
  • May mentor and coach new peers as they assimilate into this role.
  • May attend site visits as applicable in support of project delivery.

Qualifications

  • Bachelor's Degree in health care or other scientific discipline required

    • Experience

  • Ideally at least 2 years experience in clinical trial management or equivalent combination of education, training and experience.
  • Consolidated knowledge of project management practices and terminology.
  • Good knowledge of applicable clinical research regulatory requirements (GCP and ICH).
  • Broad protocol knowledge and therapeutic knowledge.
  • Understanding of the Clinical Research industry and the environments in which it operates.
  • Understanding of project finances.
  • Knowledge of clinical trials and ability to apply applicable regulatory requirements toward clinical trial conduct (ICH, GCP, and local laws).
  • Strong written and verbal communication skills in English.
  • Problem solving, organization, prioritization, and attention to detail.
  • Results-oriented with leadership and mentoring abilities.
  • IT skills including Microsoft Word, Excel, PowerPoint; ability to use other software as required.
  • Ability to establish and maintain effective working relationships with coworkers, managers and clients.
  • Ability to work across geographies with awareness of cultural differences.
  • IQVIA Core Competencies : Client Focus, Collaboration, Communication, Innovation, Ownership.

    • IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at

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    Clinical Trial Manager Iqvia Biotech • Roodepoort, Gauteng, South Africa