Senior Project Manager

Parexel International; France; À distance; EUR 50 000 - 70 000; Plein temps

Résumé du poste

Parexel International recherche un Clinical Vendor Manager expérimenté pour rejoindre son équipe, dédié à un client spécifique et gérant divers projets de recherche clinique. Le rôle offre des défis professionnels passionnants tout en permettant un équilibre de vie. Des connaissances en gestion de projets cliniques et des exigences réglementaires sont essentielles. Vous aurez l'opportunité de contribuer à des études vitaux pour la santé des patients.

Qualifications

• Expérience en gestion de fournisseurs cliniques souhaitée.
• Connaissance des exigences GxP et des processus d'authentification.
• Capacité à gérer les délais de projets et alerter proactivement les parties prenantes.

Responsabilités

• Agir en tant que point de contact unique pour l'équipe d'optimisation de l'Evidence Generation.
• Coordonner les activités de gestion des fournisseurs cliniques et superviser le processus complet.
• S'assurer que toutes les activités tierces sont conformes aux politiques internes et aux exigences réglementaires.

Connaissances

Project management

Clinical Trial Management

Regulatory knowledge

Risk management

Formation

Degree in life science or healthcare discipline

Description du poste

Parexel is currently seeking a and experienced Clinical Vendor Manager to join us. You will be assigned to one of our key sponsors in the region.

Working as a Clinical Vendor Manager at Parexel FSP offers tremendous long-term job security and prospects. We undertake vital clinical studies for sponsors including the leading global biotechs and Pharma top 50. And we have an incredible pipeline of work.

Whether you see your future path in fields such as clinical operations, project management, line management, or other positions, we have a world of opportunity waiting for you.

Our staff work from their home office base, supporting studies within their country or region. Expect exciting professional challenges in inspiring studies, but with time for your outside life.

Some specifics about this advertised role

• Dedicated to one client.
• Act as the V&TPM Single Point of Contact (SPOC) for the Evidence Generation team, providing guidance and support throughout third-party interactions.
• Coordinate V&TPM activities and responsibilities with Evidence Generation study teams (Study Execution + Evidence Generation).
• Oversee the end-to-end process, including liaison with Legal, qualification, RFP, contracting, and PO management.
• Interface with stakeholders and Novartis functions, providing inputs and updates as needed.
• Manage qualification project timelines and proactively alert stakeholders to deviations or risks.
• Ensure all third-party activities are conducted in alignment with internal policies and external regulatory requirements.
• Monitor and support risk identification, assessment, and mitigation strategies related to third-party engagements.

Here are a few requirements specific to this advertised role.

• Degree in a life science or health care discipline
• Previous experience in clinical vendor management or similar role with focus on clinical research is a plus but not required.
• Clinical Trial/Medical Affairs experience in a pharmaceutical company or a contract research organization is required.
• Project management experience in clinical operations in a pharmaceutical company or a contract research organization. Emphasis on business, experience with clinical/medical affairs processes and activities and associated external services, with excellent understanding of study management.
• Good knowledge of the regulatory requirements in Clinical Research and drug development:
• In-depth knowledge of the international pharmaceutical product development process
• Experience with GxP requirements, quality management system including risk management and regulatory requirements from main Health Authorities.
• A broad understanding of main Health Authorities standards (e.g. FDA, EMEA) and ICH regulations and guidelines.
• A broad understanding of Quality Management, GCP / GVP and Risk Management processes

We care about our people and your passion, as they are the key to our success, and provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long-term careers. In addition, you will have the opportunity to develop within your role and tackle further responsibilities or develop your skill set within other related departments of Parexel.

Who are Parexel

Parexel supports clinical studies across the full range of therapeutic areas, and we have longstanding partnerships with a vast client base.

We supported the trials of most of today’s top 50 best-selling drugs, but equally we enable more niche drug developments that are critical to the well-being of many patients.

You’ll be an influential member of the wider team.

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