Global Trial Manager, Late Phase Studies

🕒 il y a 3 mois

🌐 Espagne, Royaume-Uni, +1 autres pays – Distant

🇪🇸 Espagne – Télétravail 🇬🇧 Royaume-Uni – Télétravail 🇮🇪 Irlande – Télétravail

⏰ Temps Plein

🟡 Intermédiaire

🟠 Senior

👔 Manager

👻 Score fantôme 65%

Ce que ça veut dire : la probabilité que personne ne recrute vraiment pour cette offre.Comment le lire : 60 % ou plus, on pense que c'est une offre fantôme. Un score plus bas est moins inquiétant.Comment on la calcule : ancienneté, republications, postes ouverts vs taille de l'équipe, rapidité de clôture, et si le salaire est indiqué.À noter : une estimation à partir de données publiques, pas un jugement sur l'entreprise. De vraies offres peuvent avoir un score élevé, alors prenez-le comme un indice, pas comme un fait.

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IQVIA

Site WebLinkedInTous les Emplois

10 000+ employés

💼 Conseil

🏭 Fabrication

📣 Marketing

💰 €1 000 000 000 Post-IPO Debt en 2023-05

Consulting • Manufacturing • Marketing

IQVIA est un leader mondial dans le domaine de l'analyse de données et des solutions technologiques, dédié à l'amélioration des résultats de santé. L'entreprise utilise sa plateforme Connected Intelligence pour exploiter la puissance des analyses de données avancées et de l'intelligence artificielle, favorisant ainsi l'innovation dans le secteur de la santé. IQVIA se concentre sur divers domaines, y compris la recherche clinique, la technologie et les services de conseil, afin de résoudre des défis complexes dans le domaine de la santé et d'accélérer la livraison de nouvelles thérapies aux patients.

Description

• Lead critical aspects of global late-phase clinical studies as a core Clinical Trial Team member • Plan, coordinate and oversee assigned Medical Affairs activities from operational set-up through maintenance, reporting and closure • Act as the operational point of contact and build relationships with global stakeholders, investigators, external partners, reviewers, governance groups, CROs and vendors • Develop, coordinate, review and maintain study, program, submission and regulatory documentation • Coordinate Global Medical Affairs inputs for program-level and safety documents, including DSURs, PSURs, Investigator Brochures, Addenda to Clinical Overviews and annual regulatory reports • Organise and support kick-off, strategy, scientific review, governance and comment-resolution meetings • Maintain operational information, trackers, delegations, study or program status, metrics and reporting in systems and databases • Plan and monitor budgets and resources, including investigational product or Post-Study Drug Supply forecasts where relevant • Support selection, contracting and oversight of CROs and third-party vendors • Identify, assess and manage operational, quality, compliance, GCP and delivery risks and issues • Monitor adherence to SOPs, working practices, GCP and applicable requirements, maintaining audit and inspection readiness • Track assigned activities and outstanding items through final resolution • Contribute to process simplification, operational excellence, knowledge sharing and continuous improvement

🎯 Exigences

• Advanced degree in life sciences or healthcare • Minimum 5 years’ experience in planning, executing and reporting global clinical trials in a pharmaceutical company or CRO, preferably including at least 2 years managing Real World Evidence (RWE) or global late-phase studies (e.g. PASS, PAES, NIS), or relevant equivalent Medical Affairs experience (dependent on role pathway) • Experience working in global, cross-functional matrix teams and building effective relationships with internal and external stakeholders • Ability to manage multiple studies or programs of work in parallel, consistently delivering to time, budget and quality expectations • Strong planning, communication, influencing, problem-solving and organisational skills, with the ability to work independently and manage ambiguity and change • A quality and compliance mindset, high attention to detail and the confidence to speak up, challenge constructively and drive issues to resolution • Experience contributing to relevant clinical study documents (e.g. protocols, PSURs, DSURs, regulatory submissions) • Candidates must be based in Madrid, Spain; Reading, Berkshire, United Kingdom; or Dublin, Ireland • This role is not eligible for UK visa sponsorship

🏖️ Avantages

• Home-based work in Europe • Full-time employment

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