Sr/ Clinical Trial Manager - IQVIA Biotech

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Note: Due to sponsor requirements, only candidates located in the specified locations and with previous Global CTM experience will be considered. Applications from candidates based outside these locations will not be considered.

Job Overview

Clinical Trial Managers (CTM) are integral to clinical trial delivery, leading and working alongside clinical teams to improve patients’ lives by bringing new drugs to market faster. The CTM is a core project team member responsible for the clinical delivery of full service, large, multi-regional studies in compliance with SOPs, policies, and practices.

Essential Functions

• 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 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, planning compliance measurement, 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 CTM alongside other CTMs to deliver large, global trials.
• Identify clinical stakeholder landscape 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, including project-related training.
• 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 act 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 to support project delivery.

Qualifications

• Bachelors Degree in health care or another scientific discipline.

Experience

• Ideally at least 2 years experience in clinical trial management or 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 and therapeutic knowledge.
• Good understanding of the clinical research industry (drug/device/technology/etc.) and relevant environments.
• Understanding of project finances.
• Knowledge of clinical trial conduct and skill in applying regulatory requirements.

Seniority Level: Mid-Senior level

Employment Type: Full-time

Job Function: Research, Analyst, and Information Technology

Industry: Hospitals and Health Care

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