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Senior Clinical Project Manager (Europe)

Allucent · Warsaw

New
Hybrid Senior 🇬🇧 English
ICH-GCP(R2) Microsoft Word

Job description

About the role

Allucent helps small-to-medium biopharmaceutical companies navigate clinical trials so they can bring therapies to patients worldwide. It is looking for a Senior Project Manager to join its A-team in a hybrid or remote setting, coordinating clinical trials from start-up through final delivery. Trials focus on oncology, neuroscience, immunology and infectious diseases, with cell and gene therapy experience a plus.

Key responsibilities

  • Lead the project team and deliver the project within scope and timeline according to the contract
  • Create and execute project management plans and ensure quality, SOPs, GCP and regulatory compliance
  • Set up communication lines and escalation paths with stakeholders
  • Contribute to study documents such as protocol, CRFs, monitoring plan and Clinical Study Report
  • Define and run project-specific training plans, and lead internal and external meetings including Kick Off Meetings and Investigator Meetings
  • Support vendor identification, qualification and selection, and manage vendor relationships
  • Manage the study budget, including monthly invoicing, and produce progress and status reports
  • Run a risk management plan, handle scope changes and negotiate with internal and external teams
  • Keep the Trial Master File up to date and inspection ready, and act as main contact between sponsor and project team
  • Oversee project delivery and give performance feedback to functional managers

Required profile

  • Minimum bachelor's degree in life sciences, healthcare or business
  • Minimum 5 years of relevant experience, including at least 3 years in clinical trial project management
  • Preference for candidates with CRA experience
  • Experience managing all phases of the full-service clinical trial lifecycle (start-up, maintenance, close-out)
  • Strong financial acumen, analytical skills and excellent written and verbal communication in English
  • Outgoing, client-focused, proactive and able to work in a fast-paced environment

Required skills

  • Expert knowledge of ICH-GCP(R2), data and patient privacy practices and local regulatory requirements
  • Proficiency in Microsoft Word, Excel and PowerPoint
  • Strong presentation skills

What we offer

  • Comprehensive benefits package and competitive salary per location
  • Departmental study/training budget and access to online training
  • Flexible working hours and the option of remote or office work depending on location
  • Leadership, mentoring and career progression opportunities, plus a Buddy Program
  • Employee referral program and internal growth opportunities

Questions fréquentes

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Source : ats:workable

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Published 23 hours ago

Expires 1 month from now

12 views · 0 interested

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Allucent

Warsaw