Clinical Trial Manager
hace 4 semanas
Key Responsibilities:
As a Clinical Trial Manager at ICON, you will be responsible for coordinating and leading the local trial team to deliver quality data and trial documents/records that are compliant with assigned protocol, codes of Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and regulatory requirements.
The successful candidate will be the primary point of contact at a country level for assigned studies and will be responsible for country do-ability and site feasibility assessment in conjunction with CTA, CRA, and PM.
Key responsibilities include:
- Ensuring consistent conduct of pre-trial assessment visits and instructing teams on appropriate follow-up of pre-trial visit report and country feasibility report.
- Recommending suitable sites for selection to participate in trial.
- Collaborating with the CPL, PM, local management/Country Head, and Protocol Owner to select final site list.
- Contributes input to the Trial Plan, Safety Monitoring Plan, Filing and Archiving Plan, and Investigational Product documents at a country level or initiates development of these plans for a single country trial.
- Leads and coordinates local trial team activities in compliance with GCO Standard Operating Procedures (SOP), Work Instructions (WI), and applicable regulations.
- Ensures that all SAEs/PQCs are reported within reporting timelines and documented as appropriate.
- Maintains and updates trial management systems (e.g., CTMS, eTMF/LAF, Trial Master Source, and Sharepoints).
- Monitors country progress and initiates corrective and preventive actions when the trial deviates from plans and communicates study progress and issues to study management teams.
Requirements:
A minimum of a BA/BS degree is required. A degree in a health or science-related field is preferred. Experience as Lead CRA/LTM/CTM of at least 2 years is required. Experience in submissions is also required. Specific therapeutic area experience may be required depending on the position.
The ideal candidate will have a basic understanding of the drug development process including ICH/GCP and local regulatory requirements. Solid communication and computer skills are required. Proficient in speaking and writing in the country language and English language is also required.
What ICON Can Offer:
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, including various annual leave entitlements, a range of health insurance offerings, competitive retirement planning offerings, and a Global Employee Assistance Programme.
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