The Senior Clinical Trial Associate (Snr CTA) role supports the planning and conduct of clinical studies as a member of the study execution team (SET), and supports the Clinical Development Therapeutic Area in preparing clinical packages for regulatory submissions. The Snr CTA is able to operate with independence and is responsible for study documentation and filing, as well as timeline tracking and reporting. The Snr CTA will provide organizational and logistic support for compliance related activities, including study management, site management, monitoring oversight and trial file management.
• This role reports to Regional Head, Site Management & Monitoring
• This position does not have direct reporting responsibilities.
Main Responsibilities and Accountabilities:
• Trial Master File maintenance and filing of relevant documents according to ICH-GCP and SOPs (as required), and respective archiving and electronic filing of documents.
• Perform periodic Trial Master File quality control check through course of study as defined by study team or eTMF/QC specialist.
• Assist with the preparation/collection of all study documents (e.g. protocol, CRF, forms, manuals, etc.) and presentation materials.
• Support with study start up activities for study management or site management (e.g. review of study specific documents (trackers and metrics) provided by CRO, maintenance of country and site feasibility trackers, etc.).
• Develop tracking timelines/deliverables.
• Track various program-related activities/documents such as project team calendars, monitoring frequency, CTMS reports and others.
• Periodically distribute tracking documents to predetermined contacts.
• Responsible for organization of internal and external meetings and attendance as required.
• Prepare minutes as required (study or non-study meetings)
• Support Study Team by acting as a backup for receiving and triaging calls from investigator sites, Medical Monitor, third party vendors and any other appropriate members of project team.
• Provide logistical support for the shipping of study specific documents/materials
• Support independently with Clinical Study Report preparations.
• Support independently with Regulatory Submission preparations
• Responsible for administrative or project related tasks (e.g. review training records, review, assist and track study management tasks(e.g. CRO payments, CRO invoices, enrollment, SharePoint maintenance) and site management tasks (e.g. site payments and site invoices, as requested)
Position and Experience Requirements:
An associate degree in pharmacy, biological sciences or related disciplines is preferred or equivalent clinical research experience in lieu of degree
• Knowledge of ICH-GCP and SOPs in Clinical Research and Development
• 2-5 years’ experience in clinical trial or other drug development activities.
The candidate must possess and have demonstrated the following skills:
• Comprehensive understanding of clinical trial processes.
• Knowledge of ICH-GCP regulations and the conduct of clinical studies
• Excellent communication and training skills in English
• General written and oral communication skills
• Excellent organizational and time management skills
• Attention to detail
• Ability to work independently and as a team member in a global environment
• Planning & co-ordination
• Time management – project planning and co-ordination/implementation.
• Strategic development and analytical skills