Overview

At ICON we currently have an exciting opportunity on a sponsor dedicated Pharma client who is looking for a Senior Global Clinical Trial Lead to join their growing team. This is a permanent role through ICON and home-based.

MUST come from a clinical research background with at least 7 years experience working within a Pharma or CRO working 4 years as a global CTM/ Project Manager.

Countries we will only consider: France, Germany, Italy, Netherlands, Poland, UK, Bulgaria

Responsibilities

• Leads the development of the clinical trial strategy and delivers the clinical operational plan within the budget, timelines and quality standards agreed upon by Governance Committees.
• Accountable for oversight of CROs in the execution of Phase I – IV global clinical trial(s).
• Represents Global Clinical Operations (GCO) within the Global Trial Team and serves as the key GCO operational point of contact for the trial.
• Accountable for the successful preparation and presentation of operational content at key governance discussions (TARB, ICSC).
• Key contributor to the development of annual trial/project objectives and communicating to relevant line management and Clinical Operations Team.
• Drives and leads the successful execution, oversight and approval of all clinical trial documents and operational plans of global clinical trials using strong project management, leadership, and organizational skills.
• Ensures strong oversight, review and delivery of trial/project CAPAs in order to meet corporate compliance standards and timelines.
• Accountable for partnering with CRO in audit responses and addressing quality issues.
• Provides leadership and contributes to all operational aspects of the trial budget, including forecasts to ensure delivery within the R&D financial standards.
• Performs review and provides strong operational input in the development of clinical trial protocols, ICFs and CSRs and contributes as a member to the CTM Internal Protocol Review Committee.
• Filters, prioritizes, analyzes and validates complex and dynamic information from a diverse range of external and internal sources to respond to technical operational and organizational challenges.
• Supports the development and implementation of department initiatives including input on SOPs, processes, and workstreams.
• Ensures strong inspection readiness application for all assigned clinical trials.

Qualifications

• BS/BA in life sciences/healthcare-related discipline or RN. Advanced degree desirable (MPH, MS, MA, MBA, PharmD);PM certification (CPM, PMP) desirable.
• Minimum of 7 years in clinical research in a CRO or Pharmaceutical/Biotechnology Industry environment with at least 4 years of in-depth knowledge and experience in clinical trial management.
• Extensive experience in all aspects of clinical study planning and startup (including budget and resource planning) and in executing the complete range of clinical study activities, from startup through final study report.
• Requires substantial to extensive professional experience in relevant disciplines and substantial project management experience. Requires senior knowledge and experience in own discipline and beyond which may also require good market and competitor knowledge.
• Cross functional management experience, leading cross functional teams
• Vendor management, leading and oversight as well as vendor budgets.

Countries we will only consider: France, Germany, Italy, Netherlands, Poland, UK, Bulgaria