The Clinical Transparency & Data Sharing team is within CMO office and leads the AstraZeneca Group of Companies, Clinical Trial Transparency Position Globally. We are responsible for clinical data sharing, clinical document sharing and clinical transparency patient engagement activities such as the Lay Summaries and Thank you cards.

This role will support delivery of the AstraZeneca Clinical Trial Transparency Patient Engagement and commitments through day to day delivery of associated activities. The CTT PE Specialist will support the delivery of key CTT PE deliverables (i.e. Thank you cards, Lay Summaries, Ongoing Communications, Unblinding communications, etc.)  to all study participants in AstraZeneca sponsored studies.

The ideal candidate possesses the following:

• An understanding of clinical study delivery and the associated documents, such as protocol, CSR, ICF and essential clinical documents
• Basic project management experience for managing timelines and issues, with a willingness to grow in this space
• Ability to communicate status and report effectively to others on that status
• Strong communication skills, both written and verbal, in English
• Ability to function in a team environment as well as independently
• A keen interest in the patient’s role within a clinical study and advocating for studies that seek to achieve best practices in patient engagement

The role will ensure that the right tools and processes are used to ensure AstraZeneca’s CTT PE program is sustained, protected and delivered effectively. This role will work globally with study teams to meet the CTT Global Standards and Global Regulations. This role is will support people, processes and technology as necessary.  The role will support the Clinical Transparency & Data Sharing group deliverables as needed.

The role will be an individual contributor.

The successful candidate role models AstraZeneca values and principles and encourages others to do so.

Typical Accountabilities

• Support the delivery and oversight of all Clinical Trial Transparency Patient Engagement Activities as assumed by AstraZeneca in support of CTT Global Standards, Bioethical commitments, and global regulations.
• Identify program issues and risks.
• Lead the resolution of issues raised by study teams.
• Working closely with the study managers (GSMs) to evaluate the ICFs and other contracts and make decisions to best deliver the program for a given study.
• Tracking of large amounts of tasks to ensure the overall portfolio of studies is on track to delivery to CTT PE standards.
• Support template management for CTT PE program deliverables, such as the ‘Thank you card, Lay Summary, Ongoing communications and the Unblinding communication card templates.’
• Support CTT PE communications across AZ to ensure effective communication of requirements to all through avenues such as newsletters, social media and formal articles on Nucleus.  
• Professionally represents AstraZeneca in response to external and internal queries for report and metrics requests.
• Serves as the first line of contact for external and internal partners and a Subject Matter Expert in the CTT Patient Engagement processes and best practices
• Responsible for supporting/demonstrating compliance with established corporate standards.
• Review and contribute to departmental procedure documents related to Clinical Trial Transparency
• Supports both process and system compliance, as needed, through process documentation changes, necessary system testing activities, and overall user communication tools.
• Support development of any training materials as needed in collaboration with direct manager and other team members.
• Ensures adherence to all applicable AstraZeneca requirements.
• Support continuous improvement in process delivery through identification and implementation of best practices and efficiencies for clinical trial transparency and patient engagement.
• Successful ability to work in a cross-functional, inter-company capacity to track compliance with all Legal and Regulatory requirements pertaining to any and all applicable clinical studies that are sponsored by the AstraZeneca Group of companies.
• Other duties as assigned by line management in support of Clinical Trial Transparency and Patient Engagement.

Education, Qualifications, Skills and Experience required for the role

Essential

• Demonstrate an understanding of the key clinical study milestones and a patient’s role in clinical studies
• Proven track record for attention to detail and focus on high quality delivery
• Basic project management skills  
• Demonstrated ability to set and manage priorities, resources, goals and project initiatives
• Demonstrated success in operating in a cross functional organization, collaborating with senior leaders.
• Basic understanding of clinical trial operations and associated data
• Excellent written and verbal communication skills in English
• Demonstrated ability to work with others to achieve objectives
• Demonstrated aptitude for process and technology
• Proven experience in collaboration, interpersonal relationships, problem solving and conflict resolution skills
• Customer Focused and Performance Driven
• Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement

Desirable

• Prior experience in a similar role with good knowledge and experience in Clinical Trial Disclosure space
• Good understanding of Global Medicines Development and associated data assets
• Knowledge of lay communication principles with regards to health literacy for clinical studies
• Experience of working in a global organization with complex/geographical context
• Proven Conceptual and Analytical thinking; concern for standards and willingness to learn from others
• Experience facilitating positive solutions amongst various stakeholders
• Invites input from each person, shares ownership and visibility; creates a climate of collaboration performance and add value to the business
• Prior relevant experience in a similar role with good knowledge and experience in Clinical Trial Disclosure
• Experience managing external vendor relationships for success in day to day operations.
• Proven track record for looking at innovative ways to solve problems
• Experience working with clinical study delivery teams

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.