Sr. Clinical Project Manager; Europe

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Sr. Project Manager (Sr. PM) to join our A-team (hybrid*/remote). As a Sr. PM at Allucent, you are responsible for the overall coordination and management of clinical trials from start up through to final delivery. The trials are mainly in Oncology, Neuroscience, Immunology, and Infectious Diseases. Experience in Cell and Gene Therapy is a plus. This position directs the technical and operational aspects of clinical projects – all with the sense of urgency expected of Allucent customers.

• Leads the project team, ensuring the project is delivered according to planned scope and timelines in accordance with the contract
• Creates and executes project management plans required for project delivery and in accordance with established processes
• Ensures quality and adherence to the relevant policies, SOPs, and working instructions, GCP and regulatory guidelines.
• Establishes clear communication lines and escalation pathways, communicates with project stakeholders
• Provides input on study related documents such as the study protocol, CRF, Medical Review/Monitoring plan, and Clinical Study Report
• Establishes requirements for and ensures project specific training plan for team activities
• Leads internal and external meetings, with internal and sponsor teams, including Kick Off Meetings (KOM) and Investigator Meetings based on project scope
• Provides support for vendor identification, qualification and selection and manage vendors
• Manages vendors and vendor relationships as required for project delivery
• Ensures effective and efficient resource utilization across projects and programs
• Produces, maintains and circulates project progress and status reports
• Manages the study budget, including monthly invoicing.
• Establishes project risk management plan with input from client and functional stakeholders and oversees adherence and updates throughout the project lifecycle
• Proactively recognizes and addresses any changes in scope
• Negotiates and influences internal and external team members in a professional manner and with successful outcomes
• Effectively solves problems with projects teams by applying strategic thinking and conflict resolution skills
• Ensures the Trial Master File is kept up to date and inspection ready
• Serves as the primary point of communication between the sponsor and project team
• Leads by example and encourages team members to develop strong solutions for clinical trial delivery
• Responsible for oversight of project team delivery and communication with functional managers, including performance feedback

• Minimum Bachelor’s degree in life science, healthcare and/or business degree
• Minimum 5 years of relevant work experience
• Minimum 5 years of experience in drug development and/or clinical research, with at least 3 years of clinical trial project management experience
• Preference for candidates with CRA experience
• Expert knowledge of ICH-GCP(R2), data and patient privacy practices, and applicable (local) regulatory requirements
• Demonstrates strong financial acumen, administrative excellence and analytical skills
• Experience managing all phases of the full-service clinical trial delivery lifecycle (Start-up, Maintenance, Close-out).
• Excellent written and verbal communication, planning, critical thinking and organizational skills, including command of English language
• Representative, outgoing and client focused
• Ability to work effectively in a fast-paced challenging environment with a growing company
• Proficiency with various applications including, but not limited to, Microsoft Word, Excel, and PowerPoint required
• Strong presentation skills
• Fosters learning and the advancement and development of others
• Dependable and able to take action to quickly to address urgent needs
• Proactive and solution oriented
• Willingly takes ownership and drives positive, collaborative results with the project team
• Exercises good judgement with defined procedures…