lavori presso Iqvia in località Sud Africa

Clinical Trial Manager - IQVIA Biotech

Oncology experience required.

• Ensure clinical delivery of assigned projects in compliance with regulatory requirements (ICH-GCP protocol), customer requirements (contract), and internal requirements (policies SOPs).
• Accountable for meeting project 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 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 deliver the project 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 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.

Bachelors Degree in health care or other scientific discipline required.

• Ideally at least 2 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. GCP and ICH guidelines.
• Requires broad protocol knowledge and therapeutic knowledge.
• Requires good understanding of Clinical Research industry (drug/device/technology) 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.

Knowledge of clinical trials – Knowledge of clinical trial conduct and skill in applying applicable clinical research regulatory requirements.

• i.e. ICH and GCP and relevant local laws, regulations and guidelines towards clinical trial conduct.
• Communication - Strong written and verbal communication skills including good command of English.
• Problem solving - Problem solving skills.
• Organization - Planning, time management and prioritization skills.
• Prioritization - Ability to handle conflicting priorities.
• Quality - Attention to detail and accuracy in work.
• Results-oriented approach to work delivery and output.
• Leadership - Good influencing and negotiation skills. Good judgment and decision-making skills. Effective mentoring and training skills fostering learning and knowledge sharing with colleagues.
• IT skills - Good software and computer skills including Microsoft Word, Excel and PowerPoint.
• Collaboration - Ability to establish and maintain effective working relationships with coworkers, managers and clients.
• Cross-collaboration - Ability to work across geographies displaying a high awareness and understanding of cultural differences.
• IQVIA Core Competencies - Ability to demonstrate all IQVIA 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.

• Employment Type: Full-Time
• Experience: years
• Vacancy: 1