Remote Senior Clinical Project Manager

Summary

Join Allucent's A-team as a Sr. Project Manager and lead the coordination and management of clinical trials from start-up through to final delivery.

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 2-3 years of clinical trial project management 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

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 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
• Conducts review of initiation, monitoring and close-out visit reports
• May perform co-monitoring visits
• Ensures the Trial Master File is kept up to date and inspection ready

Preferred Qualifications

Preference for candidates with CRA experience

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/hybrid* 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 GoodHabitz and internal platforms