Project Manager with IVD Expertise
As a Project Manager with IVD expertise, you will play a key role in managing IVD studies from initiation to completion, acting as the primary point of contact for clients and ensuring high-quality, on-time project delivery. You will lead cross-functional teams to execute projects successfully within scope, timelines, and budget. By combining your deep understanding of IVD development with strong project management capabilities, you will contribute to both operational excellence and the continued growth of our dynamic MedTech CRO.
In this role, you will have the opportunity to:
- Lead the planning, execution, and management of IVD studies from initiation to completion, ensuring deliverables, timelines, and budgets are met.
- Contribute to the development of IVD project proposals and quotations, providing input on methodology, timelines, resourcing, and budgeting
- Act as the key point of contact for IVD clients, building strong and trusted relationships
- Collaborate closely with cross-functional teams and external partners to achieve study deliverables.
- Proactively identify clinical project risks, provide input to appropriate countermeasures and contingency plans, and assure implementation of action plans to reduce project risk.
- Monitor and manage project timelines, budgets, and resources effectively while maintaining a focus on integrity, transparency, and accuracy in reporting.
- Together with the team, you ensure program requirements are met and that studies are executed in a compliant, scientifically appropriate manner.
- Be highly involved in study planning and study design. Involvement in study deliverables as protocol, monitoring plan, and Trial Master Files.
The essential requirements of the job include:
- A Master of Science in a scientific, biological, or medical science field
- Minimum of 3 years’ experience hands-on experience in clinical study conduct
- Proven experience in IVD projects
- Strong experience using Microsoft applications (Excel, Word, PowerPoint, Outlook)
- Multilingual proficiency can be advantageous for international trials.
Do you recognize yourself in below Skills & Competences:
- Comprehensive IVD Study Knowledge: In-depth understanding of IVD study designs, performance evaluation requirements, operational processes, and applicable regulatory frameworks (e.g. European In Vitro Diagnostics Regulation (EU 2017/746)
- Organizational & Time Management Expertise: Skilled in efficiently managing complex projects, balancing multiple priorities, and meeting deadlines.
- Effective Communication: Skilled at conveying project goals, updates, and requirements to stakeholders, ensuring clarity and alignment.
- Strategic Problem-Solving and Decision-Making : Ability to analyze situations and make informed, timely decisions to address challenges.
- Team Leadership & Motivation: Proven track record of leading, motivating, and supporting project teams to achieve high performance and successful outcomes.
- Stakeholder Engagement & Relationship Building: Expertise in building strong, collaborative relationships with clients, vendors, and cross-functional teams to ensure project success.
- Flexibility & Attention to Detail: Adapting to changing situations while ensuring precision and adherence to standards.
- Self-Directed & Proactive: Takes responsibility for projects, initiating actions with minimal guidance.
