Manager, Clinical Trial Transparency Patient Engagement

This position is responsible for patient-facing materials delivery as required by EU Clinical Trial Regulation (EU CTR 536/2014) and Alexion public commitments to all participants taking part in Alexion-sponsored clinical trials. This role may also perform other CTT-related duties as assigned by line management. This position will function with moderate supervision as required, with dotted line reporting to AZ CTT leadership.

Principal Responsibilities

To support Alexion's mission to improve the lives of people affected by rare diseases, the Medical Writing & Clinical Trial Transparency (MW&CTT) team drives the development of strategic and regulatory‑compliant documents to enable clinical research and regulatory approval of new therapies, and ensures Alexion's continued compliance with laws, policies, regulations, and public commitments for transparency and disclosure.

The CTT PE Manager facilitates the delivery of key patient-facing materials such as thank you cards, trial results summaries (lay summaries of results), ongoing communications, unblinding communications, and lay summaries of protocol synopses to study participants in Alexion-sponsored studies globally. This role ensures that the right tools and processes are used to sustain, protect, and effectively deliver Alexion's Patient Communication Programs; works globally with study teams to meet company global standards and global regulations; supports people, processes, and technology as necessary; and follows AZ values and behaviors and encourages others to do so.

The Manager, Alexion CTT Patient Engagement, is expected to

• Serve as the first line of contact for internal partners and as a subject matter expert in the Patient Communication processes and best practices.
• Successfully work in a cross-functional, inter-company capacity to track compliance with all legal and regulatory requirements pertaining to applicable clinical studies sponsored by Alexion.
• Deliver program metrics in response to internal requests.
• Identify program issues/risks and work with external vendors and global study teams to resolve issues raised by study teams.
• Work closely with global study managers to evaluate ICFs and other documents and make decisions to best deliver the program for a given study.
• Track large amounts of tasks to ensure the overall portfolio of studies is on track to deliver to company standards.
• Support continuous improvement in process delivery through identification and implementation of best practices and efficiencies.
• Support template management for Patient Communication Program deliverables, such as the Thank you card, Trial Results Summaries, Ongoing communications and the Unblinding communication card templates.
• Contribute to the development and/or review of program procedures and guidelines.
• Support development of training materials as needed in collaboration with business process owners and other team members.
• Other duties as assigned by line management to support CTT, such as creating redacted clinical documents following established redaction guidelines and SOPs and performing quality control of redacted documents for peers, study teams, and local country staff.

Required Qualifications

• Knowledge of lay communication principles with regards to health literacy.
• Understanding of clinical study key delivery milestones and essential clinical documents, such as protocol, clinical study report, and informed consent form.
• Project management experience for managing vendors, documents, timelines, and issues.
• Proven track record for attention to detail and focus on high-quality delivery.
• Demonstrated ability to set, manage, and communicate priorities, resources, goals, and project initiatives.
• Demonstrated success in operating in a cross-functional organization and collaborating effectively with senior leaders.
• Strong communication skills, both written and verbal, in English.
• Ability to function in a team as well as independently.
• Ability to understand and adhere to defined guidelines for identification of personal information accurately and demonstrate application across numerous documents.
• Basic understanding of what it means to identify something as company confidential information (CCI).
• Proficiency in using the MS Suite of tools, including Excel, Word, and PowerPoint, as well as Adobe Acrobat Pro.

Education

• Bachelor's degree in life sciences or other relevant field.