Senior Clinical Lead, Oncology

4 weeks ago

Bloemfontein, Orange Free State, South Africa IQVIA Full time

Senior Clinical Leads 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. Within Global Study Leadership, you will work as the primary Clinical Lead alongside other Clinical Leads to deliver large, global trials within our Oncology delivery unit.

The Senior 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 (Standard Operating Procedures) SOPs, policies and practices. Senior Clinical Leads ensure clinical delivery to customers by leading clinical teams and partnering with Project Leaders and other functional teams to ensure projects meet delivery requirements at all times.

Essential Functions:

  1. Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol), customer requirements (contract), and internal requirements (policies, Standard Operating Procedures (SOPs), project plans).
  2. Accountable for meeting projects' recruitment targets and ensuring appropriate recruitment strategies are in place.
  3. Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle.
  4. Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues.
  5. 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 Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
  6. Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management.
  7. Collaborate with the clinical team to support milestone achievements. Report to internal and external stakeholders as per project scope requirements.
  8. 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.
  9. Other responsibilities include conducting regular team meetings and communicate appropriately to achieve objectives, supporting professional development of clinical team via feedback, adopt corporate initiatives and serve as a change advocate and contribute to the development of the clinical delivery strategy for business proposals.

Qualifications and Experience:

  1. Requires prior relevant experience in global trial management within oncology.
  2. Requires consolidated knowledge of Project management practices and terminology.
  3. Bachelor's Degree in health care or other scientific discipline.
  4. Requires understanding of project finances.
  5. Ability to work across geographies displaying a high awareness and understanding of cultural differences.
  6. Strong written and verbal communication skills including good command of English language.
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