Associate Director, Clinical Database Developer I

AstraZeneca

AstraZeneca

Software Engineering
Bengaluru, Karnataka, India
Posted on Sep 18, 2024

Job Title: Associate Director, Clinical Database Developer I

Career Level - E

Introduction to Role:
Join us as an Associate Director, Clinical Database Developer I in our Oncology R&D department. This role oversees the Clinical Database Development (CDD) deliverables on clinical project or therapeutic area level, ensuring harmonization and standardization of clinical databases across clinical studies within the project. As an expert on CDD processes, standards, and technology, you will support the Clinical Project Teams (CPT) with technical expertise in clinical databases. This is your chance to work on the next generation new drug modalities and experience more than traditional molecules.

Accountabilities:
As an Associate Director, you will be accountable for oversight on standardization and harmonization of clinical database deliverables across studies in the clinical project or therapeutic area. You will provide 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 the clinical project. You will also lead projects to automate, simplify and innovate in order to ensure that the team is industry leading

.

Essential Skills/Experience:
- Bachelor's degree, preferably in computing or scientific discipline
- Database development experience in the pharmaceutical industry working with clinical trial data
- 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
- Excellent understanding of clinical data system design / development / validation and system interoperability
- Ability to work independently without close supervision
- Ability to work in a global team environment
- Experience in EDC tools Medidata Rave, Inform, Veeva etc


- Excellent knowledge of clinical and pharmaceutical drug development process
- State of the art understanding of data standards (CDISC) and practices as they apply to CRF design, clinical data tabulation, database development, data handling and reporting
- 3-5 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 or Java are added advantage
- Experience with reporting environments Crystal Reports, Business Objects, Tibco SpotFire, PowerBI or Tableau are added advantage

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

At AstraZeneca, we push the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. We are a science-based, leading and decisive Oncology enterprise united in our vision to eliminate cancer as a cause of death. With one of the broadest and deepest Oncology pipelines in the industry, there are many opportunities to work with new and novel drugs and help discover what's next. We foster a mindset of courage, where everyone is empowered to step up, innovate and work at pace. We lead through true collaboration, building collective wisdom by giving everyone a chance to input. It's science with an impact-making a difference for patients and people around the world.

Ready to make a difference? Apply now and join us in our mission to eliminate cancer as a cause of death!

Date Posted

18-Sept-2024

Closing Date

30-Oct-2024

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.