Clinical Trial Manager

As a Clinical Trial Manager  you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

Local Trial Management services, provides local management of a clinical trial (or Medical Affairs data
generation activity) in a country or countries. Services/deliverables include operational oversight of assigned
protocol(s) at the country level from start-up through to database lock and closeout activities. Further, services
will ensure the local trial team is delivering quality data and trial documents/records that are compliant with
the assigned clinical trial protocol, company Standard Operating Procedures (SOPs), International Conference
on Harmonization for Good Clinical Practice (ICH-GCP), and regulatory requirements. Partners with the Clinical
Trial Assistant (CTA)/lnvestigator Document Assistant (IDA), Site Manager (SM) and Central Trial Manager
(CTM)/Global Trial Manager to ensure overall study delivery at the country level.

What you will be doing:
Services rendered will adhere to applicable SOPs, Wis, policies, codes of Good
Clinical Practice (GCP), local regulatory requirements, etc.
Contribute to quality Site Selection through participation in site feasibility ensuring consistent conduct
of pre-trial assessment visits and appropriate follow-up of pre-trial visit report and country feasibility
report. Collaborates with central study team for final selection of sites to participate in trial.
Ensures local/country team is meeting recruitment targets with high quality data on time and within
study budget by providing input to study level documents and leading/coordinating local team
activities in compliance with SOPs, other procedural documents and applicable regulations. This may
require development of local trial specific procedures and tools, recruitment planning, contingency
and risk management, and budget forecasting.
Act as primary company contact for assigned trial at the country level, may attend/participate in
Investigator Meetings as needed. May schedule and conduct a local/country investigator meeting.
Drive study compliance by maintaining and updating trial management systems, using study tools and
management reports available to analyze trial progress. When necessary initiates corrective and
preventive actions (CAPA) when the trial deviates from plans and communicates study progress and
issues to study management teams.
Contribute to site level recruitment strategy and contingency planning and implementation in
partnership with other functional areas to achieve clinical research target.
Delivers competent vendor management at the country level to support the study and may submit
requests for vendor services and support vendor selection. This includes reviewing and approving site
and local vendor invoices as required. As required, manages the local study supply.
Ensures high standards for study monitoring by conducting quality local trial team meetings and
facilitating SM training, when needed (i.e. implementation of study amendment-and changes in study
related processes).
• Contributes to patient understanding of protocol and patient safety by preparing country specific
informed consent in accordance with procedural document/templates. This includes reviewing and
managing site specific informed consent forms in accordance with SOPs, other procedural documents
and applicable regulations.
Ensures trial subject safety in that all AEs/SAEs/PQCs are reported within the required reporting
timelines and documented, as appropriate.
• Ensures Inspection readiness by maintaining complete, accurate and timely data and essential
documents in systems utilized for trial management (e.g. CTMS and eTMF/IF) according to
expectations (metrics) and archiving retention requirements. When issues are identified or trends
across a project are noted from MVR review, will escalate deviation issues to CTM/GTL and FM in
timely manner.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant
training requirements and developing therapeutic knowledge enough for role and responsibilities.
• With focus on quality, will work closely with SM to ensure CAPA is implemented for audits/inspections
or any quality related visits. May conduct accompanied site visits with SM, if delegated by FM.
• Ensure accurate finance reporting and trial delivered within budget by adhering to finance reporting
deliverables and timelines. This includes forecasting and proactive management of country/local trial
budget. If applicable, may assist in negotiation of trial site contracts and budgets.
• Keeps the trial in compliance with local regulatory requirements by organizing and ensuring IEC/HA
approvals, if applicable.
• May contribute as a mentor, champion, or representative of functional area in process initiatives, as
required.
• Full utilization by timely and accurate time reporting.
• Experience in management and startup of complex Early Phase trials projection with internal matrix
clinical teams and sites, as applicable

Requirements:

• BA/BS degree.
• Degree in a health or science related field.
• 2 years of local trial management experience.

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

At ICON, 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.

https://careers.iconplc.com/reasonable-accommodations

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.