Senior Manager Clinical Trial Lead

About the role

As a Program Manager at ICON, you will lead and manage complex projects and programs across various departments, ensuring they are delivered on time, within scope, and within budget.

Responsibilities

• Manages medium-sized global project teams with members also from outside the direct working environment.
• Coordinates stakeholders from closely related areas or even beyond.
• Demonstrates skills in successfully leading international teams in the matrix organization and directly influences and motivates people; contributes to a positive working climate.
• Coordinates operational and therapeutic area training for internal and external study team members.
• Accountable for successful project execution including definition of milestones. May also include clarification of project scope.
• Acts as an advisor and mentor within the team and beyond and may serve as best practice resource within own discipline or as technical expert on cross-functional teams or projects.
• 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 assigned trials.
• Represents Global Development Operations (GDO) within the Global Trial Team and serves as the key GDO operational point of contact for the trial.
• Accountable for the successful preparation and presentation of operational content at respective governance bodies.
• 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 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.
• 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.

Requirements

• 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.
• 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 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.
• Leadership competencies and influencing skills.
• Effective oral and written communication skills.
• Proven team dynamic knowledge and skills and ability to foster partnerships across projects and multidisciplinary teams.
• Good knowledge of drug development process, interfaces, and interdependencies of clinical development with other functions (e.g., nonclinical & pharmaceutical development, regulatory, commercial/marketing).

Benefits

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others.