Clinical Trial Application Submission Manager

**Overview**:

- As a Clinical Trial Application Submission Manager you will provide an interface to Regulatory and Global Product Development (GPD) partners within designated Business Units, offering project leadership and expertise in the logistics involved with execution of regulatory Clinical Trial Applications and Central Ethics submissions to regional partners and selected Health Authorities.

You will be accountable for working with contributing business lines to lead operational submissions execution for designated Clinical Trial Applications. You will operate as regulatory operational Subject Matter Expert for a Clinical Trial Applications and drive submission teams towards the timely delivery of globally compliant submission-ready

**Responsibilities**:
**What you will be doing**:

- Drives global submission management strategy and activities for assigned protocols. Partners with study teams, with responsibility management of required regulatory activities, standards and deliverables associated with CTA submission development including authoring of Annex I and completion of relative associated documentation as required
- Lead and attends relevant meetings to advocate realistic deliverable timelines, understand project strategy, and assess associated impact and present status of global submission delivery activities
- Support and leads global team efforts to ensure high quality components and submissions that are compliant with industry, agency and format guidelines, regulatory strategies, policies, and timelines.
- Liaises with Core team, SSU and Study Management, regarding essential core documents and local documentation as needed from relevant supplier lines across both HA and EC submission and translation processes
- Prepare, review and support submissions to HA/Regional CTA Hub, in order to obtain all necessary authorizations/approvals pertaining to the clinical trial conduct.
- Responsible for the co-ordination of translations for core documents required for submission
- Manages the compilation for core package build, contributing to CTA and authoring documentation as required
- CTA Manager may act as local country liaison when required
- Escalates, informs, and resolves any issues that may impact submission builds or the logistics of global submission delivery to regional and local partners or Health Authorities.
- Discussed with relevant SMEs the interpretation of dossier requirements

**Qualifications**:
**You are**:

- BS./B.Sc is in Pharmacy, Life Sciences,; equivalent relevant professional experience will be considered.
- In-depth understanding and proven execution of Clinical Trial Application and Central Ethics processes globally
- Proven technical aptitude and ability to quickly learn and use new software, regulations and quality standards

**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