Operational Clinical Trial Specialist

Operational Clinical Trial Specialist

As a key member of our team, you will be responsible for managing study and regional/country level activities from study startup through conduct and study close. Your primary focus will be on ensuring compliance with regulatory requirements, managing relationships with vendors, and coordinating site activation and monitoring processes.

Key Responsibilities:

• Study Management
  • Responsible for management/oversight of study and regional/country level activities from study startup through conduct and study close
  • May manage the study start up process in countries assigned (where SUPM not assigned) and/or oversee CRO responsible for these activities as applicable
  • Site identification and feasibility ensuring countries/sites can meet all study protocol requirements
  • Provides country level input on Startup and Recruitment milestones as provided by CRO and/or Country Trial Manager to Global Study Manager during planning
  • Is accountable for overseeing CRO and/or Country Trial Manager for assigned studies at country level in accordance with the overall project plan, manages and maintains accurate country level plans (e.g. timelines, budget, risk and quality plans)
• Collaboration and Communication
  • Collaborates with accountable roles to identify and manage deviations and risks in study startup and execution and implements mitigation strategies as required
  • Leader of the Local Study Team (core members: Lead Site Care Partners Clinical Trial Assistant, ad hoc members: ICL, Site Activation Partner, CTRO and Local Regulatory, Medical Affairs colleagues and other key stakeholders as required)
  • Ensures timely communication bidirectionally between the global and local study team
  • Provides protocol level guidance and support to responsible Local Study Team members as applicable
• Quality and Compliance
  • Ensures compliance to relevant Global and Local, internal and external requirements and regulations
  • Utilizes roles in country such as Lead Site Care Partner, and expert roles such as Contracts Leads, Site Activation Partners to provide the Global Teams with local intelligence and operational nuances to be considered
  • Acts as the study level point of contact for all study-level questions for the Local Study Team, ensuring resolution at lowest possible level, and when needed liaising with and escalating to appropriate global roles/teams
  • Follows up on region/country level issue status to ensure resolution
• Operational Excellence
  • Identifies country level trends to improve deliverables processes as needed
  • Utilizes country intelligence to provide input on country specific risks into preparation of Investigational Quality Management Plan, Study Monitoring Plans, ensures PTMF completeness and oversight of all relevant compliance activities for allocated studies
  • Ensures audit/Inspection readiness during start-up and conduct
  • Manages applicable Quality Events with CRO and local team as applicable and required

Required Skills and Qualifications:

• Relevant operational clinical trial experience
• A scientific or technical degree is preferred along with knowledge of clinical trial methodology
• 3~5+ years of relevant experience in BS/BSc/MS/MSc
• Working knowledge of Good Clinical Practice, clinical and regulatory operations and environment in countries under responsibility
• English is required

Benefits:

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family's needs
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised 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, subsidised travel passes, health assessments, among others

Others:

• Inclusion & belonging are fundamental to our culture and values
• We're dedicated to providing an inclusive and accessible environment for all candidates
• ICON is committed to providing a workplace free of discrimination and harassment
• All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status
• If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below
• Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles