On behalf of a Danish biotech, we are seeking an experienced and self-driven freelance Clinical Project Manager (CPM) to manage the end-to-end project leadership of pivotal First-in-Human (FIH) studies.
In this role, you will act as the sponsor’s primary project lead and be the central figure ensuring seamless execution from startup to completion. You will be responsible for driving the study forward, coordinating all internal and external activities, and ensuring that timelines, budgets, and quality standards are met. This is a flexible consultancy position around 15-20 hours/week with a duration of at least 4-5 months and the potential for extension.
Key Responsibilities
End-to-End Project Management:
* Assume the role of sponsor project manager and drive all aspects of an FIH dose-escalation study.
* Lead the project from the early synopsis stage through protocol development, plan creation, and preparation for regulatory submissions.
Internal Coordination:
* Act as the primary liaison between various internal functions, including CMC, Regulatory Affairs, Clinical Pharmacology, Data Management, and Biomarkers.
* Ensure effective communication and alignment across the organization to drive the project forward.
External Management and Communication:
* Serve as the direct point of contact for the selected Phase 1 CRO clinic conducting the study.
* Ensure a robust and proactive collaboration with all external vendors and subcontractors.
* Represent the company professionally and constructively in all external dialogue.
Operational Execution and Quality Assurance:
* Oversee and manage all startup activities to ensure an efficient and timely study initiation.
* Ensure data management is properly integrated to achieve high-quality data.
* Proactively identify risks and critical tasks to optimize timelines without compromising patient safety and data integrity.
Qualifications & Experience
- Solid and documented experience as a freelance Clinical Project Manager in the biotech (you have managed multiple FIH dose-escalation studies for other startups)
- Extensive experience leading First-in-Human (FIH) dose-escalation studies in healthy volunteers – within the last five years.
- A ‘plug-and-play’ profile with a deep, hands-on understanding of the operational machinery behind Phase 1 studies.
- Experience from a startup or small biotech environment, where you are accustomed to working independently, taking initiative, and driving tasks to completion with limited resources.
- Strong stakeholder management skills and the ability to communicate clearly and professionally with both internal teams and external partners.
- Experience running clinical studies in Europe.
- Ability to work from the office in the Greater Copenhagen area at least one day per week to ensure close coordination.
- Experience within CNS is an advantage but not a requirement; operational experience with FIH studies is prioritized.
Compensation & Benefits
- You will be compensated by either an hourly rate or a monthly retainer – the rate will be based on your qualifications and experience.
- A flexible part-time contract (approx. 0.5 FTE) with a hybrid work model, combining remote work with valuable on-site collaboration in the Copenhagen-based office.
- A central key role with significant autonomy and direct impact on a business-critical project.
- The opportunity to become an integral part of a passionate and highly competent team in a dynamic company with an exciting future.
- Potential for a long-term collaboration and the opportunity to be involved in future projects within the company’s growing pipeline.
USPs for this Job
- High-Impact Key Role: You will be the central driving force for a critical FIH study, responsible for shaping the project from start to finish with a high degree of autonomy.
- Flexible Collaboration: The job offers an attractive balance with a part-time hybrid model that recognizes the need for both flexibility and close, personal coordination in an agile environment.
- Long-Term Partnership Potential: This is more than a single project. For the right candidate, there is a clear opportunity to become a trusted, long-term partner with access to exciting tasks in an ambitious pipeline.
Application Process
If you are the experienced and proactive freelance CPM we are looking for and are ready to take the lead on this exciting project, we would love to hear from you.
For more information, please contact Senior Recruitment Consultant, Søren Spanner Bach, at Black Swans Exist Recruitment.
