Clinical Trial Manager II, IQVIA Biotech

Clinical Trial Manager II, IQVIA Biotech

IQVIA Biotech partners exclusively with biotech and emerging biopharma companies to support clinical development across all phases and therapeutic areas. We deliver tailored solutions through an agile structure, collaborative culture, and deep therapeutic expertise to help bring innovative treatments to patients faster.

Oncology & Global Experience. Clinical Leads are an integral part of clinical trial delivery, 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 the clinical delivery of clinical studies to meet contractual requirements in accordance with Standard Operating Procedures (SOPs), policies and practices. Clinical Leads ensure clinical delivery to customers, lead clinical teams and partner with Project Leaders and other functional teams to ensure projects meet delivery requirements at all times.

• 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 and manage clinical risks through the project lifecycle.
• Ensure clinical quality delivery by identifying quality standards, planning how compliance will be measured, and monitoring 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.
• 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 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.
• May contribute to the development of the clinical delivery strategy for 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 work as a primary Clinical Lead alongside other Clinical Leads to deliver large, global trials.
• May attend site visits as applicable in support of project delivery.

• Bachelor’s Degree in health care or other scientific discipline required.
• Requires 5 years clinical research/monitoring experience or an equivalent combination of education, training and experience.
• Requires basic knowledge of project management practices and terminology.
• Requires good knowledge of applicable clinical research regulatory requirements (GCP/ICH).
• Broad protocol knowledge and therapeutic knowledge.
• Good understanding of the Clinical Research industry and relevant environments.
• Understanding of project finances.
• Knowledge of clinical trial conduct and applicable regulatory requirements toward clinical trial conduct.
• Strong communication skills in English; ability to influence and negotiate; organizational and leadership abilities; problem solving and attention to detail.
• IT skills: Microsoft Word, Excel, PowerPoint.
• Ability to collaborate across geographies and establish effective working relationships.
• IQVIA Core Competencies: Client Focus, Collaboration, Communication, Innovation, Ownership.