Director Clinical Trial Transparency External Data Sharing
Job Type: Full time
Location: Warsaw (PL), Barcelona (ES) or Cambridge (UK)
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 is responsible to deliver to the AstraZeneca External Data Sharing Policy, Standard Operating Procedures and commitments. The CTT External Data Sharing Director will be accountable for end to end delivery of data requests from researchers using AstraZeneca’s data sharing management process and associated tools. The CTT Data Sharing Director will lead the External Data Sharing team. The role will seek to maximize the value from information by integrating people, processes and technologies for external data sharing and with regards to overall data sharing policies across AstraZeneca. The role will ensure that the right tools, standards and processes are used to ensure AstraZeneca’s assets are effectively protected and data sharing commitments are advanced. This role will incorporate industry best practices into the process and drive continuous improvement in data sharing. The role will collaborate with other members of the Clinical Trial Transparency Office, Data Office, Data Privacy Office, and Clinical Product Leadership teams to support delivery as needed.
This role will work globally with researchers and internal cross functional colleagues to deliver anonymized clinical data and documents to requestors. This role will not do the anonymization, but will manage the process and relationships to deliver the end to end process.
The role will be both an individual contributor and a line manager.
The successful candidate role models AstraZeneca values and encourages others to do so.
- Lead the team that serves as the primary point of contact for external researchers seeking to use AstraZeneca data for research leading AstraZeneca’s commitments to the Principles for Responsible Clinical Trial Data Sharing. Data is defined as clinical data, aggregate data, genomics data and other applicable data types as necessary.
- Demonstrate strong leadership capabilities, including the ability to set clear direction for the team and demonstrate strong people management skills.
- Be an expert in the field of data sharing. Bring best practices and novel solutions to AstraZeneca’s data sharing process ensuring global requirements and regulations are continually met in delivery.
- Manage and oversea the delivery lifecycle of External Data Requests, both internal and external, using the Vivli platform. This includes but is not limited to the following tactical delivery activities:
- Responsible for triaging Enquiries and External Data Requests to appropriate functional areas for review and approval and document process in applicable database(s).
- Along with other team members, proactively monitors the review and approval Data Requests within the applicable database(s). Responsible for sending reminders and promoting the timely completion of reviews and approvals.
- Ensures adherence to all applicable AstraZeneca requirements demonstrating compliance with corporate standards and quality procedures.
- Support continuous improvement in process delivery and evolution through identification and implementation of best practices and efficiencies for clinical trial transparency and data sharing.
- Responsible for managing access to data sharing platform tools and the associated vendor relationships necessary to deliver to AZ policies and commitments.
- Operate in a cross-functional, inter-company capacity to ensure compliance is maintained with all Legal and Regulatory requirements pertaining to any and all applicable clinical studies that are sponsored by the AstraZeneca Group of companies.
- Define, manage, monitor and evolve metrics to monitor success, challenges and opportunities.
- Supports both process and system compliance, as needed, through process documentation changes, necessary system testing activities, and overall user communication tools.
- Own External Data Sharing training materials development and evolution.
- Ensure a high focus on quality delivery, documentation and reporting.
- Serve as a cross functional representation in AstraZeneca Data Sharing Teams such as the R&D Policy Council, China HBS Governance and other forums as identified to support AstraZeneca’s overall goals in clinical data sharing.
- Participate in external working groups and task forces as necessary to further the visions, best practices and overall data sharing solutions globally.
- Review and contribute to departmental procedure documents related to Clinical Trial Transparency
- Other duties as assigned by line management in support of clinical trial transparency and data sharing.
Education, Qualifications, Skills and Experience:
- Experience in line management
- Experience in matrix management to successfully deliver projects
- Proven experience in project management skills
- Demonstrated ability to set and manage priorities, resources, goals and project initiatives
- System workflow management experience
- History of Demonstrated success in operating in a cross functional organization, collaborating with senior leaders.
- Understanding of clinical trial operations and associated data
- Excellent written and verbal communication skills in English
- Demonstrate strong communication skills and facilitation skills with the ability to work with others to achieve objectives and resolve challenges.
- Demonstrated aptitude for process and technology
- Demonstrated ability to work collaboratively in a team environment as well as independently; proven ability to facilitate team building and team work
- Excellent negotiation, collaboration, interpersonal, 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
- Demonstrate deep understanding and commitment to the Principles for Responsible Clinical Trial Data Sharing as established by EFPIA and PHRMA
- Experience collaborating in external working groups such as Transcelerate, EFPIA, Pharma, Phuse, or other similar organizations driving and delivering change.
- Good understanding of Global Medicines Development and associated data assets
- Knowledge of Best practices in System management and Validated systems delivery
- 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
- 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.
- Basic understanding of contract management
- Experience in clinical trial transparency
- Experience in clinical data sharing
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.