Expression Of Interest: Lecturer (Faculty Of Computer Science) Part-Time

Emeris; South Africa; On-site; ZAR 1,100,000 - 1,700,000; Full time

Job summary

IQVIA Biotech in Centurion, South Africa, is seeking a Senior Clinical Trial Manager for Oncology to lead delivery of large, multi-regional studies and ensure regulatory compliance and high-quality outcomes.

You will manage recruitment strategies, project finances, and risk mitigation while coordinating with global teams and external stakeholders to meet contractual requirements and timelines.

Qualifications

• Consolidated knowledge of Project management practices and terminology.
• Good knowledge of applicable clinical research regulatory requirements (GCP/ICH).
• Broad protocol knowledge and therapeutic knowledge.
• Understanding of clinical research industry and project finances.

Responsibilities

• Lead clinical delivery of large, multi-regional studies.
• Ensure regulatory compliance with ICH-GCP, protocol, and SOPs.
• Manage project finances including Estimate at Completion (EAC).
• Coordinate cross-functional teams and stakeholders to meet recruitment targets.
• Develop and maintain risk mitigation plans and quality standards.

Skills

Project management

GCP/ICH knowledge

Regulatory compliance

Stakeholder management

Education

Bachelor's degree in healthcare/science

Job description

Senior Clinical Trial Manager - Oncology - IQVIA Biotech

Centurion, South Africa
Full time
R

**Job Overview**
Clinical Trial Managers (CTM) 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 CTM 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.

**Essential Functions**

• 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).
• 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 Estimate at Completion (EAC) and identify additional service opportunities or out of scope work.
• Work as the primary CTM alongside other CTMs 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.

**Qualifications**

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

**Experience**

• Ideally at least 5 years experience in clinical trial management or equivalent combination of education, training and experience.
• Requires consolidated knowledge of Project management practices and terminology.
• Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
• Requires broad protocol knowledge and therapeutic knowledge.
• Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates.
• Requires understanding of project finances.
• Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.

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