Senior Clinical Trial Manager - IQVIA Biotech

IQVIA; Oeiras; Sur place; EUR 70 000 - 110 000; Plein temps

Résumé du poste

IQVIA Biotech seeks an experienced Clinical Trial Manager to lead and coordinate the delivery of large, multi-regional trials with clinical teams to help bring new therapies to patients. You will ensure adherence to GCP/ICH and SOPs, and you will manage recruitment and quality across the study lifecycle.

The role emphasizes strong project management, budget oversight, and proactive stakeholder communication, mentoring team members and aligning with SOPs and regulatory standards.

Qualifications

• Bachelor's degree in health care or scientific discipline.
• At least 5 years of clinical trial management experience.
• Strong knowledge of GCP, ICH guidelines and regulatory requirements.
• Experience with project finances and EAC processes.
• Experience leading global, multi-regional trials.

Responsabilités

• Lead and coordinate clinical delivery of multi-regional trials.
• Ensure regulatory compliance with GCP, ICH, SOPs and contracts.
• Manage recruitment targets and recruitment strategies.
• Develop and monitor project risk mitigation plans.
• Oversee quality delivery and track performance against plans.
• Manage project finances including EAC and changes against baseline.

Connaissances

Project management

GCP knowledge

ICH guidelines

Regulatory compliance

Stakeholder communication

Formation

Bachelor's Degree in health care or scientific discipline

Description du poste

Clinical Trial Manager - IQVIA Biotech

• Please note: due to sponsor requirements for the role only candidates based in the listed location/s and with previous Global CTM experience will be considered. Any applications from candidates based outside of these locations will not be considered.

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. 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.

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.; Req
• 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.;

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

IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.