Manager - Clinical Trial Transparency

Role & responsibilities

• 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.
• 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.

Preferred candidate profile

• The candidate 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