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Director Clinical Standards

Location Bengaluru, Karnataka, India Job ID R-141134 Date posted 20/06/2022

JOB TITLE : DIRECTOR CLINICAL STANDARDS

CAREER LEVEL: F

Leverage technology to impact patients and ultimately save lives

Do you have expertise in, and passion for, information technology? Would you like to apply your expertise to impact the IT strategy in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you!

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world’s most serious disease. But we’re more than one of the world’s leading pharmaceutical companies. At AstraZeneca we’re dedicated to being a Great Place to Work.

Director Clinical Standards is accountable for leading, managing and developing a team of standards developers in more than one country and can lead managers. Is responsible for developing the Clinical standards strategy for one or more areas of data standards development and management for clinical project. Presents a strategic mindset and management skills to run and oversee large, complex projects or multiple projects. Provide strategic direction for data standards development and governance. Leads cross-functional teams compromised of experts to deliver continuous process improvement and lead initiatives with external partners. Can contribute to external industry standards and governance groups.

Typical Accountabilities

Responsible for Line leadership of staff locally/ globally, accountable for recruitment, development and succession planning Defines objectives and strategy for team members

Accountable for the leading in one or many areas of clinical data standards

Provides strategic direction of clinical data standards development, maintenance and governance.

Technical subject matter expert in one or many areas of clinical data standards serving as a resource for others within and beyond the Biometrics function

Responsible for the development of standard methodologies to improve quality, efficiency and/or effectiveness within function

Contributes or leads to training and mentoring within and beyond the Biometrics function

Contributes or leads cross-functional or process improvement initiatives

Responsible for defining/maintaining a robust governance framework and best practice for clinical data standards at AZ Contributes to external industry standards and governance groups

Education, Qualifications, Skills and Experience

Essential

BSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science or equivalent experience.

Excellent clinical data standards and/or Data Management and/or Programming and/or Statistics experience in Pharmaceuticals/Healthcare and/or Clinical Drug/Medical Device Development

Experience developing and delivering end-to-end clinical data standards, including standards governance mechanisms

Strategic attitude and thinking with ability to translate strategy to operational execution

Proven organisational, people, and line management leadership skills with globally distributed teams

Able to motivate and empower a diverse team in a matrix organisation

Excellent collaboration and communication skills required – needs the energy to work across global & functional boundaries

Demonstrate an entrepreneurial approach, the identification, demonstration, and delivery of new value-oriented standard solutions

A clear demonstration of behaviours of truth seeking rather than success seeking

Agile responsiveness to industry and business needs

Embracing of peer review

Ability to influence relevant partners on standards related items

Desirable

Understanding of programming languages (eg, SAS, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Pearl)

Current knowledge of other technical and regulatory requirements relevant to the role

Significant proven experience designing and implementing business processes

In depth knowledge of clinical trial processes

WHY JOIN US ?

We’re a network of high-reaching self-starters who contribute to something far bigger. We enable AstraZeneca to perform at its peak by delivering premier technology and data solutions.

We’re not afraid to take ownership and run with it. Empowered with unrivalled freedom. Put simply, it’s because we make a significant impact. Everything we do matters.

SO, WHAT’S NEXT?

Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?

Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

50056673 F CDPR R&D BioPharmaceuticals

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Glassdoor logo Rated four stars on Glassdoor

Great culture, great work assignments, supportive management. Rotation opportunity within the company. They value inclusion and diversity.