As a Clinical Trial Manager you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
The Clinical Trial Management provides local management of a clinical trial.
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)/Investigator Document Assistant (IDA), CRA, and Central Trial Manager (CTM)/Global Trial Manager to ensure overall study delivery at the country level.
Deliverables:
Services rendered will adhere to applicable sponsor SOPs, WIs, policies, codes of Good Clinical Practice (GCP), local regulatory requirements, etc.
Complies with relevant training requirements.
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 CRA 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 CRA to ensure CAPA is implemented for audits/inspections or any quality related visits. May conduct accompanied site visits with CRA, 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 Late Phase (2-3) trials projection with internal matrix clinical teams and sites, as applicable.
Requirements:
- 2+ years of Clinical Trial Management experience
- Autonomy with execution of local trial management services
- Depth of knowledge with local trial management services.
- Process leadership.
- Degree in the sciences
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, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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, color, 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.
