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Clinical Project Manager (H/F/X)

January 29th 2024

QbD supports companies worldwide in the life sciences throughout the entire product lifecycle, from idea to patient. With more than 450 quality experts, QbD is your partner for advice and support.

Mission Description

The Clinical Project Manager is responsible for site and project management related to clinical trials, ensuring that milestones, timelines, budget and quality of such trials, as outlined by the study protocol, monitoring plan, SOPs, and applicable regulations and policies are met.

Main Responsibilities:

  • Strategizes, oversees and coordinates successful execution clinical studies.
  • Ensures that the rights and well-being of subjects are protected, that the reported study data are accurate, complete, and verifiable from source documents, and that the study is conducted in accordance with protocol, standard operating procedures, ISO/GCP and other applicable regulatory requirements.
  • Is responsible for the overall documentation and adequacy of conduct, data quality, compliance and adherence to timelines for their assigned trial(s).
  • Oversees quality of data collection, management of study supplies and resources in adherence with the project timelines, budget and quality standards
  • Oversees start-up, enrollment, follow up and closure of clinical trial activities
  • Develops clinical study protocols and reviews/approves supporting documentation (such as monitoring plan, study plan, data management plan etc.)
  • Develops patient recruitment and retention plans
  • Reports and presents to core teams and upper management
  • Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors.
  • Establishes and cultivates a wide range of business relationships to facilitate completion of assignments
  • Interacts with and manages vendors and stakeholders, as required
  • Determines goals and objectives for projects
  • Leads projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.
  • Represents the organization as a prime contact on contracts or projects. Develops and manages the study budget. Overall responsibility for negotiation of financial aspects of clinical studies / program.
  • Interacts with senior internal management and external personnel on significant matters often requiring coordination between involved team members and stakeholders.
  • Uses discretion, diplomacy and tact to resolve difficult situations. Escalates serious issues to management.
  • Participates in the development and coaching the study team.

Candidate profile

  • Master degree in biological or (para-) medical sciences or equivalent by experience
  • Minimum of 7 years’ experience in clinical research or equivalent by education or relevant experience
  • Minimum of 2 years’ experience as Clinical Project Leader and previous experience as a CRA is a plus
  • Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook)
  • Demonstrates ability to manage and oversee projects and related team activities
  • Demonstrates ability to make timely and well-reasoned decisions
  • Demonstrates ability to effectively and persuasively communicate verbally and in writing
  • Demonstrates ability to identify and adapt to shifting priorities and competing demands
  • Ability to maintain composure in difficult circumstances
  • A true QbD’er can be recognised by the following qualities:
    • Resilient: Your strong and positive attitude helps you overcome any challenge
    • Hungry for knowledge: You are always open to learning
    • No BS mentality: you can be straightforward in a respectful way
    • Innovative: You are constantly looking for new and better solutions
    • (Not too) serious: your job is serious, but you don’t take yourself too serious.

Offer

An attractive and complete salary package:

  • A monthly wage, car, fuel card, (super fast) bicycle, insurance package, meal vouchers, etc.

But most of all…

  • We offer sustainable careers and meaningful connections
  • We are a knowledge based company 
  • You’ll work for an award winning company: Best Managed Company (Deloitte award), Baanbrekende Werkgever, …

Our promise to you:

  • As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences.
  • Moreover, we aim to create a joyful community where you dare to be and can be yourself. Because the best way to grow is by growing together as unique individuals.
  • In short … We stand for JPEG: Joy in Partnership, going for the Extra mile to Get things done!

Contact Details

Send us your CV and motivation letter and who knows, maybe you’ll find your #QbDream job.

https://qbdgroup.com/en/jobs/vacancies/clinical-project-manager/