About Axcellant
Axcellant is a boutique Clinical Research Organization supporting pharma, biotech, and innovative sponsors in the execution of complex, high-impact clinical trials—including oncology, rare diseases, radiopharmaceuticals, advanced diagnostics, and other demanding study designs.
We combine senior-level involvement, operational agility, and scientific depth with a pragmatic, partner-driven approach. As we scale our commercial footprint in Europe and beyond, we are looking for a Business Development Manager who can help shape our growth trajectory—not just execute a sales plan.
This role is ideal for someone who thrives in lean, high-ownership environments, understands how sponsors buy CRO services, and is motivated by building something meaningful rather than selling at scale.
The Role
As Clinical Project Manager, you will be responsible for leading the end-to-end delivery of international clinical trials across IMP and medical device programs, ensuring timelines, quality standards, budget expectations, and regulatory obligations are met.
You will act as the operational lead for assigned projects – from study start-up through close-out – working closely with sponsors, CRAs, regulatory specialists, vendors, and senior leadership. This is a hands-on, high-impact role with direct visibility across strategic and operational decision-making.
Key Responsibilities
- Lead international clinical trial projects from start-up through close-out across IMP and medical device studies
- Serve as the primary operational contact for sponsors and internal cross-functional teams
- Develop and maintain integrated project plans, timelines, risk registers, communication plans, and governance structures
- Drive study execution in line with protocol, contract, budget, SOPs, and applicable regulatory requirements
- Oversee project finances, resourcing, milestones, forecasting, change orders, and issue escalation
- Coordinate cross-functional delivery across Clinical Operations, Regulatory Affairs, Data Management, Safety, Medical Writing, Quality, and external vendors
- Ensure inspection-readiness and strong study oversight through proactive risk identification and mitigation
- Support or lead bid-defense meetings, proposal review, and strategic input for complex opportunities when relevant
- Contribute to sponsor retention through high-quality communication, transparent project leadership, and solution-oriented delivery
- Mentor project team members and help strengthen Axcellant’s operational standards as the organization scales
What We’re Looking For
- 3–5+ years of experience leading international clinical projects within a CRO, sponsor, or similarly regulated clinical research environment
- Strong clinical operations background with proven experience in both IMP and medical device trials
- Solid understanding of global study delivery, including vendor oversight, country coordination, and cross-functional team leadership
- Demonstrated ability to manage project timelines, budgets, risks, and sponsor communication independently
- Strong working knowledge of ICH-GCP, trial oversight, and inspection-readiness expectation
- Fluency in Regulatory Affairs relevant to clinical development, with particular strength in:
- EU CTR / Regulation (EU) No 536/2014
- CTIS management
- EU MDR / Regulation (EU) 2017/745
- ISO 14155
- US FDA 21 CFR regulations, especially those relevant to drugs and devices
- Experience in nuclear medicine / radiopharmaceutical projects is highly preferred
- Experience in oncology, rare disease, advanced diagnostics, or other complex study designs will be considered a strong advantage
- Excellent communication, stakeholder-management, and problem-solving skills
- Fluency in English; additional European languages are a plus
- Comfortable working independently in a lean, expert-led organization where quality, speed, and ownership matter
What We Offer
- A central project leadership role in a fast-growing boutique CRO focused on demanding, high-value studies
- Direct exposure to senior leadership and meaningful influence on delivery standards and client relationships
- High degree of autonomy, flexibility, and trust
- Opportunity to work on scientifically and operationally complex international programs
- Competitive compensation aligned with experience and scope
- Remote-friendly working model with regular collaboration across Europe and beyond