Senior Clinical Project Manager (Europe)
Allucent · Warsaw
Job description
About the role
Allucent helps small-to-medium biopharmaceutical companies navigate clinical trials so they can bring therapies to patients worldwide. It is looking for a Senior Project Manager to join its A-team in a hybrid or remote setting, coordinating clinical trials from start-up through final delivery. Trials focus on oncology, neuroscience, immunology and infectious diseases, with cell and gene therapy experience a plus.
Key responsibilities
- Lead the project team and deliver the project within scope and timeline according to the contract
- Create and execute project management plans and ensure quality, SOPs, GCP and regulatory compliance
- Set up communication lines and escalation paths with stakeholders
- Contribute to study documents such as protocol, CRFs, monitoring plan and Clinical Study Report
- Define and run project-specific training plans, and lead internal and external meetings including Kick Off Meetings and Investigator Meetings
- Support vendor identification, qualification and selection, and manage vendor relationships
- Manage the study budget, including monthly invoicing, and produce progress and status reports
- Run a risk management plan, handle scope changes and negotiate with internal and external teams
- Keep the Trial Master File up to date and inspection ready, and act as main contact between sponsor and project team
- Oversee project delivery and give performance feedback to functional managers
Required profile
- Minimum bachelor's degree in life sciences, healthcare or business
- Minimum 5 years of relevant experience, including at least 3 years in clinical trial project management
- Preference for candidates with CRA experience
- Experience managing all phases of the full-service clinical trial lifecycle (start-up, maintenance, close-out)
- Strong financial acumen, analytical skills and excellent written and verbal communication in English
- Outgoing, client-focused, proactive and able to work in a fast-paced environment
Required skills
- Expert knowledge of ICH-GCP(R2), data and patient privacy practices and local regulatory requirements
- Proficiency in Microsoft Word, Excel and PowerPoint
- Strong presentation skills
What we offer
- Comprehensive benefits package and competitive salary per location
- Departmental study/training budget and access to online training
- Flexible working hours and the option of remote or office work depending on location
- Leadership, mentoring and career progression opportunities, plus a Buddy Program
- Employee referral program and internal growth opportunities
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Published 20 godzin temu
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Allucent
Warsaw
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