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QbD GroupQG

Experienced Project Manager IVD CRO

QbD Group is a leading European expert in quality assurance and regulatory compliance, providing services across the medical device and pharma industries.

QbD Group

Employee count: 501-1000

United States only

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Qarad’s IVD CROis a clinical research organization (CRO) specializing in In Vitro Diagnostics (IVD), providing full-service solutions to support diagnostic development from concept to commercialization. With a growing portfolio of projects, we are dedicated to delivering high-quality outcomes through excellence in project execution and governance.

We are seeking a dynamic and experienced Project Managerto join our team, specializing inclinical performance studies for In Vitro Diagnostic devices (IVD).

You will play a critical, dual role within our organization. On the one hand, you manage individual high-value, strategic projects that align with our business goals. On the other hand, you will take responsibility for overall project planning and ensuring the successful execution of all projects within the IVD CRO organization. This includes driving adherence to project governance procedures, supporting study coordinators, and implementing tools and processes to enhance project management capabilities in an efficient and dynamic way.

The role requires an experienced, hands-on leader with strong organizational skills, and proven experience in managing complex projects. If you're ready to make a significant impact in a role that combines organizational skills, and customer engagement, we invite you to join our team and help us drive the future of clinical performance studies.

What do we expect from you as a sr Project Manager IVD CRO?

Project Governance and oversight :

  • Oversee the planning and execution of all projects within the team, ensuring adherence to project governance processes and ensuring efficient follow up of interdependent projects.
  • Support and guide Study Coordinators, enabling them to achieve success and deliver consistent results.
  • Implement project management tools, and templates across the team to increase operational efficiency.
  • Continuously monitor project portfolios for risks, deviations, and resource utilization, driving actions for improvement as needed.

Project Management :

  • Lead the planning, execution, and deliveryof critical strategic projects, ensuring timely and high-quality outcomes within budget.
  • Serve as theprimary point of contact for clients and stakeholders, fostering strong relationships, transparency, and effective communication.
  • Identify risks, create mitigation plans, and ensure proactive issue resolution to keep projects on track.
  • Develops and manages the study budget. Overall responsibility for negotiation of financial aspects of clinical performance 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.

Who are we looking for?

  • Master’s, or Ph.D. in a relevant scientific discipline (e.g., Biomedical Sciences, Biotechnology, Bioscience Engineering, ...) or equivalent by experience
  • Minimum of 7 years’ experience in project management, with a proven track record in a CRO, IVD, medical device, or life sciences environment.
  • Experience with managing complex, cross-functional projects with global stakeholders.
  • Exceptional leadership, communication, and stakeholder management skills.
  • Pragmatic and hands-on.
  • Proven ability to develop and implement project management tools, systems, and best practices.
  • Stronganalytical and problem-solving skillswith a strategic mindset.
  • High attention to detail and organizational skills.
  • Ability to identify and adapt to shifting priorities and competing demands
  • Excellent interpersonal skills; Team player
  • Ability to make timely and well-reasoned decisions
  • Abilityto effectively and persuasively communicate verbally and in writing
  • Sensitive to cultural differences
  • Fluent in English. Other languages are a plus
  • Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook)

A true QbD’er can be recognized 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 non-sense 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.

What’s in it for you?

  • QbD Group offers you an attractive and competitive salary package, that will be tailored to individual needs, considering legal requirements and local laws and regulations.
  • Join us to build a sustainable career, where job security is ensured, and lasting, meaningful connections are formed.
  • As we’re a knowledge-based company, you’re guaranteed to embark on a continuous journey of learning and development.
  • Be part of our global success story. As an award-winning company we value everyone’s contribution and celebrate achievements together

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 communitywhere 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!

Interested?Send us your CV and motivation letter and who knows, we might welcome you soon in our QbD family!

About the job

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Posted on

Job type

Full Time

Experience level

Education

Postgraduate degree

Experience

7 years minimum

Experience accepted in place of education

Location requirements

Hiring timezones

United States +/- 0 hours

About QbD Group

Learn more about QbD Group and their company culture.

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QbD Group is the European Expert specialized in quality assurance, regulatory compliance, clinical services and digital solutions for the Medical Device, IVD, Pharma and Biotech industry.

As a service partner for companies worldwide, QbD Group ensures compliance with the highest quality and safety standards. The company boasts over 750 specialists equipped with deep expertise across a diverse range of life sciences sectors, offering unmatched knowledge and insights to address complex challenges. They provide comprehensive lifecycle support from early-stage development through to patient care, ensuring seamless progression of projects.

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