Chef principal des essais cliniques, IQVIA Biotech/Senior Clinical Trial Manager, IQVIA Biotech

IQVIA Biotech collabore exclusivement avec des entreprises de biotechnologie et des sociétés biopharmaceutiques émergentes pour soutenir le développement clinique à toutes les phases et dans tous les domaines thérapeutiques. Notre structure agile, notre culture collaborative et notre expertise thérapeutique approfondie nous permettent d'offrir des solutions sur mesure qui contribuent à accélérer l'accès des patients à des traitements innovants.

IQVIA Biotech est à la recherche d'un(e) Chef principal des essais

IQVIA Biotech collaborates exclusively with biotechnology companies and emerging biopharmaceutical companies to support clinical development across all phases and therapeutic areas. Our agile structure, collaborative culture, and deep therapeutic expertise enable us to offer tailored solutions that help accelerate patient access to innovative treatments.

IQVIA Biotech is seeking a Senior Clinical Trial Manager with oncology experience and a global perspective.

Clinical Trial Managers play a vital role in the conduct of clinical trials. Working closely with clinical teams, they contribute to improving patients' lives by accelerating the commercialization of new medicines. As a key member of the project team, the Clinical Trial Manager is responsible for conducting clinical studies to meet contractual requirements, in accordance with Standard Operating Procedures (SOPs), policies, and best practices. They ensure the successful execution of clinical trials for clients, lead clinical teams, and collaborate with project managers and other functional teams to guarantee adherence to execution requirements at every stage.

Essential Functions:

• Ensure the execution of clinical trials for assigned projects, in accordance with regulatory requirements (International Conference on Harmonisation (ICH) - Good Clinical Practice (GCP), protocol), client requirements (contract), and internal requirements (policies, standard operating procedures (SOPs), project plans).

• Ensure that project recruitment targets are met and implement appropriate recruitment strategies.

• Contribute to the development of the project risk management plan and manage clinical risks throughout its lifecycle.

• Ensure the quality of clinical trials by identifying quality standards and requirements, planning compliance assessment methods, and monitoring and managing clinical quality issues.

• Manage the clinical aspects of project funding, including the Estimate at Completion (EAC). Understand the scope of clinical delivery and develop plans for its implementation. Track and manage changes to the baseline Estimate at Completion (EAC) and identify opportunities for additional services or out-of-scope work.

• Identify and manage the project's clinical stakeholders, both internal and external, through effective communication and rigorous issue management.

• Collaborate with the clinical team to achieve established objectives. Report to internal and external stakeholders as required by the project.

• Plan the clinical team's resources and talent. Coach the clinical team at the project level to ensure its success through the implementation of high-quality operational plans, appropriate training, and mentoring.

• Lead regular team meetings and communicate effectively to achieve objectives.

• Contribute to professional development by providing feedback to the clinical team's frontline managers on their performance against project tasks.

• Participate, as appropriate, in the development of the clinical delivery strategy for proposals. Participate in the preparation and presentation of proposals. Develop and present the clinical operations plan in partnership with business development and project management.

• May mentor and train new colleagues during their onboarding.

• May act as a lead clinical manager alongside other clinical managers for the execution of large-scale international clinical trials.

• May participate in site visits, as required, to support project execution.

Qualifications

• Bachelor's degree in health sciences or another scientific discipline required.

• 5 years of experience in clinical research/monitoring or an equivalent combination of education and experience required.

• Basic knowledge of project management practices and terminology required.

• Sound knowledge of regulatory requirements applicable to clinical research, including Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines.

• In-depth knowledge of protocols and therapeutic aspects.

• Understanding of the financial aspects of projects.

IQVIA est un fournisseur mondial de premier plan de services de recherche clinique, d'informations commerciales et de renseignements sur les soins de santé pour les secteurs des sciences de la vie et de la santé.  IQVIA se consacre à accélérer le développement et la commercialisation de traitements médicaux innovants pour aider à améliorer les résultats des patients et la santé de la population dans le monde entier. Pour en savoir plus, visitez https://jobs.iqvia.com

IQVIA est fière d’être un employeur souscrivant au principe de l’égalité d’accès à l’emploi. Tous les candidats qualifiés seront pris en considération pour un emploi sans égard à la race, la couleur, la religion, le sexe, l’orientation sexuelle, l’identité de genre, l’origine nationale, le handicap, l’âge, l’état matrimonial ou tout autre statut protégé par la loi applicable.  Des mesures d’adaptation pour les candidats handicapés sont disponibles sur demande dans tous les aspects du processus de recrutement. Si vous avez un handicap qui nécessite une mesure d’adaptation, nous vous encourageons à contacter notre équipe d’acquisition de talents au workday_recruiting@iqvia.com, afin qu’IQVIA puisse soutenir votre participation au processus de recrutement.

IQVIA s’engage à faire preuve d’intégrité dans son processus de recrutement et applique une politique de tolérance zéro en matière de fraude des candidats. Toutes les informations et toutes les qualifications soumises dans votre candidature doivent être véridiques et complètes. Toute fausse déclaration, présentation trompeuse ou omission importante au cours du processus de recrutement entraînera la disqualification immédiate de votre candidature, ou la cessation d’emploi si elle est découverte ultérieurement, conformément aux lois applicables. Nous apprécions votre honnêteté et votre professionnalisme.

Veuillez noter qu'il est possible que nous utilisions l'intelligence artificielle (IA) dans le traitement de votre candidature. Cependant, nous utilisons l'IA uniquement pour aider notre équipe de recrutement à sélectionner ou à évaluer les candidatures, et non pas pour remplacer la prise des décisions par les membres de notre équipe.

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 proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, marital status, or any other status protected by applicable law.  Accommodations for applicants with disabilities are available in all aspects of the recruitment process upon request. If you have a disability that requires an accommodation, we encourage you to contact our Talent Acquisition Team at: workday_recruiting@iqvia.com, so that IQVIA can support your participation in the recruitment process.

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.

Please note that we may use artificial intelligence (AI) in the processing of your application. However, we only use AI to assist our recruitment team with the screening or assessment of candidacies, and not as a substitute for human decision-making.