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Clinical Research Manager

Pauwels Consulting | Diegem | Permanent, Independent, Full-time

Published on Jobat.be 11 days ago

Pauwels Consulting is a Belgian consulting firm with more than 520 experts in engineering, life sciences and IT. We offer consulting, project management and recruitment services to leading companies in Belgium and beyond. We have offices in Belgium, France, Germany and Switzerland (https://www.pauwelsconsulting.com/about/contact/) .

Clinical Research Manager

Job description

The Clinical Research Manager is responsible for Clinical R&D activities for assigned projects, including: 

  • Develop 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)
  • 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 teams interface and collaboration with key opinion leaders, investigators, IRBs/ECs, 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
     

Profile

Functional and Technical Competencies:

  • 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
  • Ability to provide strategic and scientific clinical research input across NPD and LCM projects, including complex and / or transformational projects
  • Proven track record in delivering clinical programs within clinical / surgical research setting, on time, within budget and in compliance to SOPs and regulations
  • Comprehensive understanding of clinical trial regulations across multiple regions
  • Ability to lead teams to deliver critical milestones, including complex projects
  • Ability 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
Leadership Competencies:
  • Strong leadership required in alignment 
  • Connect - foster strategic partnerships with key internal & external stakeholders to ensure development and timely delivery of innovative EGS / EDS
  • Shape - build strong relationships with external stakeholders to shape and influence relevant policies
  • Lead - continually develop expertise to provide strategic and scientific clinical research capability
  • Deliver - ensure clinical programs are delivered on time, within budget and in compliance to regulations and SOPs
  • Know and follow all laws and policies that apply to one's job, and maintain the highest levels of professionalism, ethics and compliance at all times

Offer

  • Challenging projects based on your interests and skills
  • Personal follow-up and clear, transparent communication both before and after commencement of employment
  • Possibility to follow extra training
  • Inspiring network events and legendary after work drinks
  • Strong network of industry leading clients
  • Expertise within IT, Engineering and Life Sciences
  • A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

Interested?

Bezoek pauwelsconsulting.com voor meer informatie over de vacature Clinical Research Manager of solliciteer online op de vacature Clinical Research Manager.

Vilvoorde - Zaventem

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Characteristics

Requirements

  • Master (University or Higher Education Long Type)

Offer

  • Permanent
  • Independent
  • Full-time
  • Company car

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