Senior Clinical Trial Transparency Associate

Pharmaceutical Research Associates, Inc; United Kingdom; On-site; GBP 35,000 - 65,000; Full time

Job summary

Join a leading clinical research organization as a Senior Clinical Trial Transparency Associate, where you will play a crucial role in overseeing the clinical transparency processes for global studies. This position offers the opportunity to ensure compliance with laws and regulations while collaborating with various departments. You will manage documentation, monitor regulatory changes, and provide feedback to leadership, all within a supportive and diverse culture that values high performance. The company offers competitive salaries and a range of benefits designed to promote well-being and work-life balance for you and your family.

Benefits

Various annual leave entitlements

Health insurance offerings

Retirement planning offerings

Global Employee Assistance Programme

Life assurance

Flexible optional benefits

Qualifications

• 5 years experience in the pharmaceutical industry with a focus on transparency.
• Working knowledge of clinical drug development and trial protocols.

Responsibilities

• Manage clinical transparency and public disclosure processes for studies.
• Monitor global regulatory requirements affecting clinical transparency.
• Facilitate the review and approval process for clinical trial registrations.

Skills

Organizational Skills

Attention to Detail

Pharmaceutical Industry Experience

Clinical Trial Knowledge

Education

Bachelor’s Degree

Job description

Overview

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

You will oversee and execute the clinical transparency (i.e., registration, updates and/or results disclosure) or public disclosure processes for assigned studies and/or assets conducted by client globally.

Responsibilities

What you will be doing:

• Manage the creation and maintenance of clinical transparency or public disclosure process documents while ensuring adherence to all applicable laws, regulations, industry guidance and corporate position.
• Monitor and interpret global regulatory requirements and the industry environment affecting clinical transparency or public disclosure and communicate changes to the fellow team members, partner departments and department stakeholders.
• Assess requirements for clinical trial registration / disclosure of results or public disclosure strategy plans.
• Make appropriate decisions regarding the applicability and timing of clinical transparency or public disclosure activities according to national laws, regulations, industry guidance and corporate position.
• Manage the review and approval process for clinical trial registrations, registration updates, results disclosures or public disclosure strategy plans or public disclosure tracking mechanisms, including communication with partner companies or collaborators.
• Facilitate periodic review of active registrations or public disclosure strategy plans to ensure records are updated or verified as required.
• Provide feedback to Clinical Transparency or Public Disclosure leadership resulting from new and updated transparency requirements.

Qualifications

You are:

• Bachelor’s Degree, or equivalent experience required.
• 5 years pharmaceutical industry experience required with experience in Transparency and/or Disclosure activities.
• Working knowledge of clinical drug development and clinical trial protocols.
• Excellent organizational skills and high attention to detail.
• Healthcare professional background preferred.

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.