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 deliver to the AstraZeneca Data Sharing Policy and commitments. The CTT Data Sharing Manager will be accountable for end to end management of data requests using AstraZeneca’s data sharing management process and associated tools. The role will seek to maximize the value from information by integrating people, processes and technologies. The role will ensure that the right tools and processes are used to ensure AstraZeneca’s assets are effectively protected. The role will cooperate with other members of the Clinical Trial Transparency Office to support delivery as needed. The CTT Data Sharing Manager will support the Clinical Transparency & Data Sharing group deliverables as needed.
This role will work globally with individual deliver anonymized clinical data and documents to requestors. This role will not do the anonymization, but will manage the process that considers all requests and drives to decisions.
The role will be an individual contributor with possibility to manage staff.
The successful candidate role models AstraZeneca values and principles and encourages others to do so.
- Management and oversight of applicable AstraZeneca Data Requests, both internal and external, and all applicable tracking/routing internally/externally until final execution within the Data Request management System. Data is defined as clinical data, aggregate data, genomics data and other applicable data types as necessary.
- Responsible for triaging Information/Data Requests to appropriate functional areas for review and approval and document process in applicable database(s).
- Responsible for managing access to data sharing platform tools. This will require successful vendor management.
- Working 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.
- 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.
- Serves and manages the first line of contact for receipt of all AstraZeneca external data requests.
- Professionally represents AstraZeneca in response to external and internal queries for report and metrics requests.
- 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.
- Demonstrates a high focus on quality delivery, documentation and reporting.
- Support continuous improvement in process delivery through identification and implementation of best practices and efficiencies for clinical trial transparency and data sharing.
- Other duties as assigned by line management in support of clinical trial transparency and sharing.
- Proven experience in basic 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.
- Basic understanding of clinical trial operations and associated data
- Excellent written and verbal communication skills in English
- Demonstrate good communication skills and facilitation skills with the ability to work with others to achieve objectives
- 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
- 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