Clinical Trial Manager - IQVIA Biotech

IQVIA; Limpopo; On-site; ZAR 500,000 - 700,000; Full time

Job summary

A leading global provider of clinical research services is seeking a Clinical Trial Manager in Limpopo, South Africa. You will be responsible for managing clinical trial delivery, ensuring compliance with regulations, and leading clinical teams to achieve recruitment and quality targets. Ideal candidates will have a Bachelor's Degree in a related field and at least 2 years of experience in clinical trial management. This position offers an opportunity to impact patient outcomes positively.

Qualifications

• 2+ years of experience in clinical trial management or related fields.
• Strong knowledge of project management and regulatory requirements.
• Ability to manage clinical team and financials effectively.

Responsibilities

• Ensure project compliance with regulatory and customer requirements.
• Accountable for project recruitment targets and strategies.
• Manage clinical quality and financial aspects of projects.
• Conduct team meetings for operational planning and updates.
• Mentor new peers and perform site visits as required.

Skills

Clinical trial management

Project management

Regulatory requirements knowledge

Stakeholder management

Team leadership

Education

Bachelor’s Degree in healthcare or scientific discipline

Job description

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 SOPs, policies and practices.

Responsibilities

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP; protocol), customer requirements (contract), and internal requirements (policies, SOPs, project plans).
• Be accountable for meeting project recruitment targets and ensure appropriate recruitment strategies are in place.
• Contribute to the development of the project risk mitigation plan and manage clinical risks through the project lifecycle.
• Ensure clinical quality delivery by identifying quality standards, planning how compliance will be measured, and monitoring and overseeing management of clinical quality issues.
• Manage clinical aspects of project finances including Estimate at Completion (EAC). Understand project scope and create delivery plans; monitor and manage changes against baseline 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 the clinical stakeholder landscape for the project and manage 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.
• Lead resourcing and talent planning for the clinical team. Manage the clinical team at the project level to deliver through high-quality operational plans, 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.
• 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 the 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 to support project delivery.

Qualifications

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

Experience

• Ideally at least 2 years of experience in clinical trial management or an 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; ability to apply clinical research regulatory requirements to trial conduct.
• Good understanding of the Clinical Research industry (drug/device/technology) and the environments in which it operates.
• Understanding of project finances.
• Knowledge of clinical trials, trial conduct, and applying ICH/GCP and relevant local laws, regulations, and guidelines to clinical trial conduct.

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 https://jobs.iqvia.com