ICON Strategic Solutions · 5 hours ago
Clinical Trial Governance Principal
United States
Full-time
Remote
Senior Level
6+ years expICON plc is a world-leading healthcare intelligence and clinical research organization. The Clinical Trial Governance Principal will support the execution and operational aspects of the Clinical Trial Governance processes, focusing on timelines, budget, quality, risk, and innovation.
Pharmaceuticals
Responsibilities
Assist in implementing governance strategies in collaboration with cross-functional teams
Provide operational support for clinical trial governance processes, including training and reference materials, ensuring alignment with organizational goals
Liaise with Clinical Data Strategy & Management to build and maintain automated governance dashboards for measuring both timeline and budget metrics across clinical trials
Prepare quarterly Governance timeline and budget reporting and metrics, including insights and trends
Support study teams in governance practices and provide guidance on operational challenges
Participate in the development and refinement of governance policies and practices
Coordinate cross-functional projects and ensure effective communication among stakeholders
Identifies and resolves technical and operational problems, understands broader impact on the department
Provides strategic input to solve complex problems while exercising judgment using multiple sources of information
Deep understanding of concepts and principles in own discipline. Basic knowledge of other disciplines. Responsible for managing technical tasks or assigned as a SME for more than one area
Maintain understanding of the stakeholder landscape and identify areas for alignment across stakeholders
Communicate clear and convincing opinions, ideas, and positions, tailored to the audience, in a poised, confident, and convincing manner
Develop solutions that fully address business needs and align standards
Guides others either internally or externally to adopt a different point of view
Guided by policies and departmental plan, impacts the team’s ability to achieve objectives
Qualification
Required
Bachelor's degree in a life sciences discipline or equivalent
Typically requires 6 years of experience, or the equivalent combination of education and experience
Advanced understanding/knowledge of GCP, ICH guidelines and Health Authority regulations
Advanced/In-depth understanding of relevant Clinical Research and industry trends
Advanced knowledge in system/technical tools and processes
Advanced data visualization and analytics
Lead cross-functional projects of high complexity with cross-functional team members within and outside department
Prioritizes work accordingly to meet departmental needs, work toward and meet deadlines with minimal supervision
May lead a department or sub-department initiative
Applies understanding of the business and how own area integrates with others to achieve departmental objectives
Excellent critical thinking, decision making and problem-solving skills
Responsible for aligning with workforce planning for resourcing needs
Experience with site/process audits and regulatory inspections
Demonstrated attention to detail and accuracy in a fast-paced environment
Results oriented
Strong interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team
Excellent verbal and written communication and presentation skills
Experience managing external vendors
Significant experience with guiding and coaching employees
Adapts plans and priorities to meet short term objectives
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.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
H1B Sponsorship
ICON Strategic Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
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