Descrizione dell'offerta
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.
Responsibilities
- 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 manages 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
- 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
- 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