Manager, Clinical Trial Transparency

Responsible to plan, lead and coordinate activities for submissions documents related to redaction/anonymization activities for Health Canada PRCI and EMA Policy 0070. Ability to work independently with project team, develop a schedule designed to meet necessary deadlines for a particular project, communicate with team members about that schedule, and track the progress to assure the timely completion of the tasks. The person is accountable to set up a process for the respective task, identify any risks, consider the cross-functional collaboration and feedback on an ongoing basis.**What you will be doing**:- Leads and establishes the process for- either the redaction/anonymization activities of personal data/company confidential information in clinical documents according to applicable guidelines and local laws as well as ensures timely delivery of anonymization reports when applicable and / or- Participates to the development and maintenance of- the commercial confidential information (CCI) strategy in close collaboration with the content experts and coordinates the CCI redactions/anonymization and preparation of justification documents as needed and- the general translation and translation validation strategy of submission relevant documents in close collaboration with content experts to assure the maintenance of translation convention and consistency of high-quality submission documents- Organizes a kick-off meeting for a clinical data transparency submission and trains relevant functions within sponsor on the processes and guidelines- Coordinates cross-functional teams, run comment resolution-meetings as required, develop a project plan (including required resources and cost planning), track and communicate progress and address and escalate issues as required- Maintains and updates the rules for the personal data redaction/anonymization according to local laws and regulatory authority guidelines as applicable- Trains relevant functions within sponsor on applicable submission processes and guidelines- Manages the vendor interactions for the relevant submission documents- Provides document management expertise to all redaction/anonymization or translation validation related processes and ensures all deliverables are provided according to set timelines and with excellent quality- Ensures all deliverables are provided according to set timelines and with excellent quality- Interfaces with Health Authority in collaboration with sponsor regulatory, as needed (e.g. Health Canada PRCI PIM Meeting)- Trains new colleagues as needed**You are**:- The incumbent must have at least a Bachelor degree, advanced degree is preferred and at least 3 years of experience in the pharmaceutical industry.- The incumbent must have strong English and communication skills, both written and verbal are essential and global working experience is preferred- The incumbent should have excellent electronic document management and IT-skills and willingness to test and implement new tools and platforms for redaction/anonymization tasks and processes- The incumbent must be able collaborate effectively in teams and feel comfortable interacting with people in all hierarchy levels- Ability to work efficiently, precisely and independently- Experience in project management, process development and/or coordination- Vendor management experience**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