Global Clinical Project Manager

Overview

As a Global Clinical Project Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. This is a permanent role through ICON on FSP, sponsor dedicated to a global pharma and fully home-based, full-time.

You must be working currently as a Global Clinical Project Manager within a CRO or Pharma setting with strong vendor management experience. 

Countries: Poland, Spain, UK, Italy, Portugal. 

Responsibilities

What you will be doing:

• Lead the Study Management Team including providing updates to all trial team members on deliverable status.
• Ensure availability of required reports to support real time tracking of trial status according to trial plan.
• Manage timely and accurate documentation and communication of trial progress.
• Ensure that the Study Management Team (SMT) operates in a constant state of inspection-readiness.
• Act as primary contact for Country and Regional staff.
• Act as the primary contact person for the local teams
• Partner with the Global Trial Lead to execute and oversee central activities from planning, trial start up, through the life of trial to close-out.
• Ensure issue escalation and drive issue resolution.
• Work closely with Trial Team to ensure CAPAs are resolved timely. Act as CAPA owner or contributor, as appropriate.
• Contribute to data collection to support the site selection process.
• Participate in feasibility, providing recommendations as needed.
• Establish enrollment commitments and ensure actual enrollment meets projected commitments across the regions at the clinical trial level.
• Ensure the availability of robust recruitment/contingency plans are in place for each region
• Ensure timely tracking and filing in appropriate systems, as required at central trial oversight level.
• Perform Annual Quality Review of files, as appropriate.
• Ensure archiving and retention of documents per set requirements.
• Establish country budgets and monitor actuals vs. forecast for Out of Pocket Expenses.
• Oversight of selected vendors and status of related deliverables.
• Review and approve assigned vendor invoices/spend.
• Monitor budgets and expenditures as expected per planned trial budget.
• Create and update trial-specific documents as required; including Monitoring Guidelines, Informed Consent Form, Investigational Medicinal product (IMP) related documentation, Blinding Plan, country and site feasibility related documents.
• Provide input into cross functional documents such as safety related documents, protocol deviations and issue escalation processes, External Service Provider Oversight Plan and the Filing and Archiving Plan.
• Provide central documents required for HA/EC/IRB submission.
• Ensures creation of appropriate trial-specific training materials and requirements, making them available to the regional/site/CRO staff and delivering training as needed.
• Responsible for the set-up, coordination, attendance participation of Investigator Meetings.
• Establish and maintain excellent working relationships with internal stakeholders, such as country representatives, data management leader and clinical supplies unit.
• Demonstrate deep knowledge of protocol and procedures and adequate therapeutic area knowledge.Ensure compliance with Health Authority regulations and guidelines and internal standard operating procedures and processes.
• Participate in preparation for, and conduct of, Health Authority inspections and internal audits.
• Work with Bioresearch Quality & Compliance (BRQC) liaisons to ensure quality oversight of assigned trial utilizing the available tools.
• Coordinate data cleaning with some supervision towards a timely and successful database lock.Act as central expert for assigned protocol(s).
• Sufficient therapeutic knowledge to support defined CTM roles and responsibilities.
• Contribute to process improvement and training, as applicable.
• Lead and/or participate in special initiatives, task forces, as assigned

Qualifications

You are:

 

• BS degree or equivalent, in Life Sciences (e.g., Biology, Chemistry, Biochemistry, Nursing, Pharmacy).6 years clinical trial management experience in the pharmaceutical industry or CRO.
• Specific therapeutic area experience.
• Strong working knowledge of ICH-GCP, local laws and regulations.
• Superior clinical research operational knowledge. Proven track record in successfully managing various aspects of trials from start-up to database lock and trial closure.
• Demonstrated effective leadership to proactively drive the Study Manag