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

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.