Sr. Clinical Project Manager (Europe)

Allucent; Deutschland; Hybrid; EUR 90.000 - 130.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits

Flexible hours

Remote/office depending on location

Professional development budget

Mentoring opportunities

Zusammenfassung

Allucent seeks a Sr. Project Manager to coordinate clinical trials from startup to delivery, across Oncology, Neuroscience, Immunology, and Infectious Diseases.

The role combines hybrid and remote work, leading teams, managing budgets, timelines and vendor relationships, with an emphasis on quality and regulatory compliance. Ideal candidates have 5+ years in drug development/clinical research, strong communication skills, and familiarity with ICH-GCP(R2) and regulatory requirements, plus the

Qualifikationen

• Bachelor’s degree in life science, healthcare or business.
• Minimum 5 years of relevant work experience.
• 5+ years in drug development/clinical research with 3+ years in trial PM.
• Expert knowledge of ICH-GCP(R2) and data privacy.
• Strong financial acumen and analytical skills.
• Excellent written and verbal communication; English proficiency.

Aufgaben

• Lead the project team to deliver scope on time and within contract.
• Create and execute PM plans per processes.
• Ensure quality, SOP adherence, GCP and regulatory compliance.
• Manage study budget, invoicing and risk.
• Lead meetings with sponsor teams and internal stakeholders.
• Oversee vendors and vendor relationships.

Kenntnisse

Bachelor’s degree

5+ years experience

Clinical trial PM

ICH-GCP

Financial acumen

Communication skills

English proficiency

MS Office

Ausbildung

Bachelor's degree in life science/healthcare/business

Tools

Microsoft Word

Excel

PowerPoint

Jobbeschreibung

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 role your 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

Requirements

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 needsProactive 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

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 …