Sr. Clinical Project Manager (Europe)

Allucent; Lombardia; Hybride; EUR 70 000 - 110 000; Plein temps

Avantages offerts par ce poste

Flexible Working hours

Remote/office flexibility depending on

Buddy Program

Training budget for development

Internal growth opportunities

Employee referral program

Résumé du poste

Allucent is seeking a Senior Project Manager to lead clinical trials across Oncology, Neuroscience, Immunology and Infectious Diseases with a focus on start-up to close-out delivery. You will oversee study budgets, vendor management, RM, quality, and regulatory compliance, working with sponsor teams and cross-functional groups in a hybrid/remote setting.

The role requires a life science, healthcare or business degree, at least 5 years in drug development or clinical research and strong

Qualifications

• Requires a minimum Bachelor’s degree in life science, healthcare and/or business.
• At least 5 years of relevant work experience in drug development or clinical research.
• Expert knowledge of ICH-GCP(R2), data privacy practices, and regulatory requirements.
• Strong financial acumen, administrative excellence and analytical skills.

Responsabilités

• Leads the project team and ensures delivery within scope and timelines.
• Develops and executes project management plans per established processes.
• Manages study budget, invoicing, and vendor relationships.
• Ensures quality and adherence to GCP, SOPs, and regulatory guidelines.
• Maintains Trial Master File and serves as primary sponsor-team liaison.

Connaissances

Project management

Leadership

Communication

Financial acumen

Problem solving

English proficiency

Regulatory knowledge

Formation

Bachelor's degree in life science, healthcare and/or business

Outils

MS Word

MS Excel

MS PowerPoint

MS Project

Description du poste

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 or 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.

In this roleyour key tasks will include:

• 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

To be successful you will possess:

• 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 and policies to determine appropriate action

Benefits of working at Allucent include:

• Comprehensive benefits package per location
• Competitive salaries per location
• Departmental Study/Training Budget for furthering professional development
• Flexible Working hours (within reason)
• Opportunity for remote/office* working depending on location
• Leadership and mentoring opportunities
• Participation in our Buddy Program as a new or existing employee
• Internal growth opportunities and career progression
• Financially rewarding internal employee referral program
• Access to online soft-skills and technical training via ADP and internal platforms

Disclaimers:

*Our office work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.”