At AllucentTM, 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
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