Clinical Strategy Project Manager

Coloplast

Humlebæk, Denmark

You take on a strategic role

As a project manager, you will work in a dynamic environment and lead the clinical strategy track across the product lifecycle. Depending on the project scope, you will coordinate a cross-functional team of internal and external stakeholders. Together, you will define and execute the clinical evidence strategy, generating the appropriate mix of pre- and post-market evidence - from traditional clinical investigations to post-market clinical follow-up surveys, case series, real-world evidence, registries, health-economic evidence and scientific publications. You will also provide strategic scientific and clinical advice and deliver high-quality clinical documentation.

A key responsibility will be to align with R&D, Marketing, Market Access, Regulatory Affairs and the Payers & Evidence leadership team. You must therefore be able to collaborate and communicate effectively across all levels of the organization, from senior management to core project team members.

Your key responsibilities will be to:

Lead the clinical strategy track in projects by defining an integrated evidence plan covering the pre- and post-market clinical activities required to support R&D, Regulatory Affairs, Market Access and market uptake
Engage and align critical stakeholders throughout the project
Ensure that activities are delivered on time, to the required quality and within the agreed budget
Keep management informed of progress, decisions and key risks
Contribute to strategic, regulatory and operational documentation
Identify risks related to the clinical strategy and develop appropriate mitigation plans

Pragmatic mindset and clinical experience

We are looking for an ambitious and pragmatic person who drives projects forward, challenges established ways of working and turns ideas into action. You bring a strong scientific background and the judgment to select evidence approaches that are both rigorous and fit for purpose. You understand clinical processes and the guidelines and regulations governing medical and clinical research. Just as importantly, you bring positive energy, a genuine can-do attitude and a great sense of humor to a collaborative team environment.

Moreover, you bring:

Relevant experience in project and/or team management within the clinical or medical field
Experience in clinical development, clinical project management, medical affairs or medical marketing, with a focus on communicating and reporting clinical outcomes
Experience in external networking and managing external partners and key opinion leaders
Experience working with international, cross-border teams and/or organizations
Experience in biomedical research and a solid understanding of clinical and statistical methodology
The ability to create clarity, maintain an overview and deliver results in a complex, fast-paced environment
Persistence, sound judgment and the confidence to provide direction
A relevant master’s degree
An open and positive mindset, a pragmatic can-do attitude and a great sense of humor
Excellent written and spoken English communication skills