Job title: Associate Director, Clinical Database Developer II
Company: AstraZeneca
Job description: JOB TITLE : ASSOCIATE DIRECTOR, CLINICAL DATABASE DEVELOPER II
CAREER LEVEL: E
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.
ABOUT ROLE
Oversees the Clinical Database Development (CDD) work on therapeutic or technical area level ensuring harmonization and standardization of clinical databases across clinical studies within the therapeutic or technical area. An expert on CDD processes, standards and technology. Supports the Clinical Project Teams (CPT) with technical expertise in clinical databases. Responsible to ensure CDD work you’re doing follow standards and meet data quality on therapeutic or technical area level. Maintains Business Continuity for CDD processes and standards including integrity of the clinical database for the relevant therapeutic or technical area.
Typical Accountabilities
Accountable for oversight on standardization and harmonization of clinical database work across clinical projects in the therapeutic or technical area
Provides project level technical expertise to Clinical Project Teams, data management, medical, analysis and reporting and study management teams throughout all study start up activities in therapeutic or technical area
Works in collaboration with the clinical project level representatives of other technical groups, data management, analytics and reporting to define harmonized requirements for delivering clinical studies across the therapeutic or technical area
Works in collaboration with the standards group for defining and maintaining therapeutic or technical area level standards related to clinical database development
Ensures compliance to GCP, GAMP and other global guidelines in delivering clinical databases for clinical studies across the therapeutic or technical area
Shares a point of view in solving complex programming requirements related to CDD
Governs the Clinical Data Management Systems global and program standards libraries for the therapeutic or technical area
Leads projects to automate, simplify and innovate in order to ensure that the team is industry leading
Supports the organization in defining the digital strategy for delivering future CDD activities
Accountable for delivering CDD activities within budget for the managed therapeutic or technical areas
Accountable for appropriate resourcing of managed therapeutic or technical areas
Accountable for appropriate training of reporting teams within managed therapeutic or technical areas
May act as backup for the Head of Clinical Database Development
May be asked to perform programming, testing and specification writing activities in the CDD scope.
Mentor and train Database Developers
Education, Qualifications, Skills and Experience
Essential
Bachelor’s degree, preferably in computing or scientific subject area
Database development experience in the pharmaceutical industry working with clinical trial data.
Experience in working with matrix organizations
Excellent Clinical trial knowledge
Excellent organizational and analytical skills and high attention to detail
Excellent written and verbal communication skills, organized and ability to lead tasks from concept to delivery
Excellent planning, resource and project management skills.
Solid grasp of clinical data system design / development / validation and system interoperability.
Ability to work independently without close supervision
Ability to work in a distributed team environment
Desirable
Vision to deliver digital strategy for Clinical Database Development
Excellent knowledge of clinical and pharmaceutical drug development process
Powerful understanding of data standards (CDISC) and practices as they apply to CRF design, clinical data tabulation, database development, data handling and reporting
5+ years line management experience
Excellent ability to work effectively with external partners
Demonstrates professionalism, diplomacy, mutual respect and the ability to manage/value diversity and cultural differences and promote productivity through encouragement
Experience with Medidata’s Rave Study Build
Experience in Medidata Rave Custom Functions
Experience or knowledge of Rave Safety Gateway, TSDV
Experience with object-oriented programming using .NET technologies, C#, Visual Basic, MS SQL, SAS, Python, APEX, PL SQL, XML, Java an advantage
Experience with reporting environments Crystal Reports, Business Objects, Tibco SpotFire, PowerBI, Tableau
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
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.
Date Posted 22-Jun-2022
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.
Expected salary:
Location: Bangalore, Karnataka
Job date: Fri, 24 Jun 2022 07:55:43 GMT
Apply for the job now!