Manager, Clinical Trial Transparency, Data Sharing

The Clinical Transparency & Data Sharing Team sits within Chief Medical Office and leads the AstraZeneca Group of Companies, Clinical Trial Transparency Position Globally. Weare responsible forclinical data sharingandclinical document sharing.

This role will support delivery of the AstraZenecadatasharingpolicy and commitments throughday to daydelivery of associated activities necessary to share AstraZeneca’s data safely. The CTT Data Sharing Manager will understand scientific research andbe responsible forend to endmanagement ofassigned  requestsusing AstraZeneca’s data sharing management system and associated processes. The role will advise customers on how to access and retrieve data andseekto maximize the value from information by integrating people,processesand technologies. The role will ensure that the right tools and processes are used to ensure AstraZeneca’s assets are effectively protected. The role will support the Clinical Transparency & Data Sharing group deliverables as needed.

This role will work globally to deliver anonymized clinical data and documents to requestors. This role will not do theanonymization, butwill manage the process that considers all requests and drives to decisions.The role will be an individual contributor.

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

Typical Accountabilities

• Management and oversight of applicable AstraZenecaexternaldatarequests, and all applicable tracking/routing internally/externally until final execution within the validated system known asVivli.  Data is defined as clinical data, aggregate data, genomicsdataand other applicable data types as necessary

• Responsible for triaginginformation/datarequests 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 ismaintainedwith alllegal andregulatory requirementspertaining toany and allapplicable clinical studies that are sponsored by the AstraZeneca Group of companies

• Along with other team members, proactivelymonitorsthe review and approvaldatarequests within the applicable database(s)

• ProfessionallyrepresentsAstraZeneca in response to external and internal queries for report and metrics requests

• Responsible for supporting/demonstratingcompliance with established corporate standards

• Review and contribute to departmental procedure documents related toclinicaltrialtransparency

• 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

• 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.

​Essential

• Attention to detail and ability to focus

• Demonstrated ability to work collaboratively in a team environment as well as independently; proven ability tofacilitateteam building andteam work

• Experience with basic project management skills  

• Demonstrated ability to set and manage priorities, resources,goalsand project initiatives

• History ofdemonstratedsuccess inoperatingin a cross functionalenvironment

• Basic understanding of clinical trialsand associated data

• Excellent written and verbal communication skills in English with ability to present content to seniorstakeholders

• Demonstrategood communicationskills and facilitation skills with the ability to work with others to achieve objectives

• Demonstrated aptitude for process and technology

• Customerfocused andperformancedriven

• Demonstrates professionalism, diplomacy, mutualrespectand the ability to manage/value diversity and cultural differences and promote productivity through encouragement

• Basic understanding of scientific research

​Desirable

• Good understanding ofglobalmedicinesdevelopment and associated data assets

• In-depth understanding of scientific research

• Knowledge ofbest practices insystem management andvalidated systems delivery

• Experience of working in a global organization with complex/geographical context

• Provenconceptual andanalytical 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 

• Experience managing external vendor relationships for success inday to dayoperations.

• Basic understanding of contract management