[Remote] Clinical Trial Governance Principal
Note: The job is a remote job and is open to candidates in USA. ICON 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.
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
Skills
• 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 Overview
• ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services. It was founded in undefined, and is headquartered in Dublin , GB, with a workforce of 10001+ employees. Its website is https://www.iconplc.com/services/strategic-solutions/.
Company H1B Sponsorship
• ICON Strategic Solutions has a track record of offering H1B sponsorships, with 1 in 2023, 1 in 2022, 2 in 2021, 3 in 2020. Please note that this does not guarantee sponsorship for this specific role.
Apply Now
Apply Now
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
Skills
• 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 Overview
• ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services. It was founded in undefined, and is headquartered in Dublin , GB, with a workforce of 10001+ employees. Its website is https://www.iconplc.com/services/strategic-solutions/.
Company H1B Sponsorship
• ICON Strategic Solutions has a track record of offering H1B sponsorships, with 1 in 2023, 1 in 2022, 2 in 2021, 3 in 2020. Please note that this does not guarantee sponsorship for this specific role.
Apply Now
Apply Now