Retourner aux résultats

CLINICAL RESEARCH MANAGER

Select Projects Antwerpen | Diegem | Intérim option contrat fixe, Durée indéterminée, Indépendant, Temps plein

Select Projects is part of an international full-service Human Resources organization: Select HR. Select Projects specializes in offering solutions through projectsourcing. From our offices in Belgium, the Netherlands and Dubai, we provide support to companies who need experienced specialists / project staff in several areas. We distinguish ourselves by our good follow-up and service to all our customers and our employees.

CLINICAL RESEARCH MANAGER

Description de la fonction

For one of our pharmaceutical clients in Diegem we are currently looking for a CLINICAL RESEARCH MANAGER.

Operating on behalf of the Medical Device Group, you will have strong scientific expertise to provide insights and strategic direction to develop innovative evidence generation and dissemination strategies (EGS / EDS) for New Product Development and Life-Cycle Management (NPD and LCM) projects.

Reponsibilities: 

  • Reports to the Franchise Platform Leader or Sn Clin Res Mgr, MD CR&D
  • Responsible for Clinical R&D activities for assigned projects, including
  • Develop and deliver appropriate Global EGS / EDS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant CR&D partners and cross-functional partners (e.g. Global Strategic Marketing, Medical Affairs, Regulatory Affairs, HEMA, R&D, etc), ensuring cross- functional alignment
  • Responsible for delivery of assigned clinical projects, through effective partnership with the Clinical Operations and BSDM teams, to enable optimized engagement leading to delivery of clinical project commitments (delivery on time, within budget and in compliance with regulations and SOP)
  • Ensure input and strong alignment from key regional MD CR&D leads and other strategically important countries/regions in the development of the EGS / EDS
  • Lead in study design to develop appropriate clinical trials to meet the NPD / LCM needs
  • Lead in appropriate interpretation and dissemination of all evidence generated, based on EDS, including Clinical Study Reports, abstracts, manuscripts, CERs etc.
  • Contribute in clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc, including during sponsor regulatory inspections
  • Responsible for team’s interface and collaboration with key opinion leaders, investigators, IRB’s/EC’s, Regulatory Agencies, societies, associations, etc
  • Foster strong relationships with external stakeholders to shape and influence relevant policies, etc.
  • Partner with internal stakeholders to ensure accurate dissemination of clinical data/evidence in value briefs and technical summaries for market access and reimbursement

Profil

  • You have a Bachelor’s degree in Biological Science or related discipline with a minimum of 8 years related scientific / technical experience, including leadership / management role within Clinical Research
  • You have a thorough understanding of clinical research science and processes along with a broad and extensive understanding of product development processes, team dynamics, related healthcare market environment, clinical trends and global clinical trial regulations
  • You are able to provide strategic and scientific clinical research input across NPD and LCM projects, including complex and/or transformational projects
  • You have a proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOP's and regulations
  • You have comprehensive understanding of clinical trial regulations across multiple regions
  • You can lead teams to deliver critical milestones, including complex projects
  • You are able to collaborate across different functional areas within CR&D to ensure alignment with governance processes (assigning roles and responsibilities, setting priorities, managing deliverables, etc). and to meet business objectives
  • You have demonstrated ability to build collaborative relationships with key internal and external partners and stakeholders
  • Leadership requirement – you can influence, shape and lead without direct reporting authority
  • You have experience in effective management of project budget processes

Offre

You will receive an attractive salary package with interesting fringe benefits, all in an exciting work environment where you have the ample opportunity to grow and to develop.

Cette offre d'emploi n'est plus disponible.
Vilvorde - Zaventem

D'autres ont aussi consulté

Le job a été sauvegardé

Vous pouvez retrouver vos jobs sauvegardés sur la page d'accueil ou dans Mon Jobat.

Pour pouvoir les consulter également sur d'autres appareils, connectez-vous.

Postuler maintenant

Ce job n'est plus disponible

Caractéristiques

Exigences

  • Master (Licence, Université ou Enseignement Supérieur de Type Long)

Offre

  • Intérim option contrat fixe
  • Durée indéterminée
  • Indépendant
  • Temps plein
  • Voiture d'entreprise

Recevez de nouveaux jobs par email

Recevez de nouveaux jobs pour 'Chef de projet R&D - Vilvorde - Zaventem' dans votre boîte mail.

Nous ne vous enverrons pas de publicité.