CTA

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

What you will be doing:

• 
  Responsible for the design, planning and conduct of PSP, ensuring resource and time allocation for completing all activities:
• Co-ordinate with all PSP stakeholders (POP Champion/ Procurement/ Legal/ Patient Safety/ Compliance), as appropriate
• Responsible for obtaining the appropriate approvals (compliance and POPsys) for conduct of PSP in a timely manner
• Responsible for the overall management of the External Service Provider (ESP)/Healthcare Professional (HCP), being the main point of contact and ensuring the following activities are completed prior to the beginning of ESP services
• conduct of POP Supplier Quality Assessment (SQA) and other supplier qualifications (Information Security and Risk Management (ISRM)/Third-Party Assessment Service (3PAS), Anti-Bribery), as applicable
• contract execution, including Pharmacovigilance and data privacy language, and ESP AE training
• In collaboration with the Source Data Verification Responsible (SDVR), responsible for identifying source documents and ensuring they are clearly communicated to the ESP/HCP and local POP stakeholders
• Enter program details in the POPsys database throughout the conduct of the PSP
• Ensure required data is obtained to conduct monitoring activities (Adverse Event Reconciliation (AER) and Source Data Verification (SDV))
• Keep track of all required activities (FPFC/LPLC dates, AER, SDV, closure, etc.) related to PSP conduct and ensure completion before program closure in database
• Regularly interact with the POP Champion and the Pharmacovigilance Responsible (PVR) in order to discuss PSP and ESP performance and compliance, and collaborate with them to actively follow-up on cases of non-compliance, including late AE reporting, and to ensure appropriate action and risk mitigation (deviations and CAPAs)
• Ensure compliance with all local laws and regulations
• Support during internal/external audits and inspections as needed
• Ensure proper handover of activities when leaving the role/organization/planned leaves and liaise with POP Champion as required
• Develop program materials for PSP based on approved scheme and ensure them in compliance with company guidance.
• Maintain and file relevant key documents including g-folder and hardcopy files with each event master binder (e.g. approval form, minutes, signed contract, vendor QC, etc.)
• Manage and evaluate vendor based on KPIs mentioned in contract
• Execute financial and legal activities (development of contract, review process via CLM, payment via SRM) in accordance with internal procedure.
• Ensure quality check on all regular reports from vendor
• Execute the drug delivery with quality check on application forms
• Reconcile the enrollment forms and relevant evidences against delivered drugs or refunded amounts on a regular basis to ensure that the right support is reaching to right patients
• Track and share program status with internal stakeholders
• Resolve any issue on PSP through timely notice internally and externally
• Ensure reporting and follow up of all spontaneous adverse events (AE) and technical complaints for all Novartis products according to respective SOP

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You are:

• No of years’ experience: 2 yrs
• Education: Degree, Healthcare or Life Sciences qualification preferred
• Languages:     Good command of English (oral and written).
• Medical affairs operation preferred
• Pharmaceutical Industry experience an advantage
• Good communication and interpersonal skills
• Excellent organizational skills
• Appropriate computer skills
• Artistic and creative abilities with an eye for detail
• Good understanding of relevant local laws and regulations
• Diligent worker, able to perform under pressure     

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.