Senior Standards Developer II – RAVE Subject Matter Expert
Job Title: Senior Standards Developer II – RAVE Subject Matter Expert
Career Level - D
Introduction to role
Are you ready to make a significant impact in the field of clinical data standards? As a Senior Standards Developer II – RAVE Subject Matter Expert, you will be at the forefront of developing, managing, and maintaining complex data collection and cleaning components within the RAVE Global Library of Clinical Data Standards. Your expertise will drive technical solutions for data collection and cleaning, ensuring adherence to industry and company standards. This role demands high technical proficiency and deep industry knowledge, allowing you to independently perform standards tasks while exercising sound judgment in complex situations. You will lead RAVE component deliverables and serve as the main point of contact and subject matter expert for cross-functional projects.
Accountabilities
Develop, manage, and maintain high complexity data collection and cleaning components in the RAVE Global Library.
Monitor and update requests, recommending impacts and possible implementations.
Perform independent quality control.
Plan and lead team activities and tasks.
Ensure the quality of your deliverables and oversee the quality of other developers.
Contribute to the development of best practices for developing, maintaining, and publishing data standards consistently.
Collaborate with and contribute to Clinical Standards governance groups.
Provide expert support to drug projects on AZ Clinical Standards in line with technical expertise.
Assist with metric reporting on standards and requests.
Manage activities of external partners.
Serve as a technical subject matter expert in specialized areas of clinical standards (RAVE components).
Contribute to function recruitment, training, and mentoring.
Essential Skills/Experience
BSc in Information Sciences, Mathematical, Statistical, Computer Science or Life Science or equivalent experience.
5+ years’ experience in RAVE.
Experience in RAVE custom functions programming.
Medidata study build certificate (SDBE) is required.
Experience and knowledge in optimizing existing form design including knowledge and guidance on best practices around use of field attributes, log forms, dynamics, edit check actions, custom functions, derivations.
Experience in validation process.
Good knowledge of Rave Safety Gateway is an added advantage.
Advanced CSharp programming skills are an added advantage.
Knowledge of MS Excel, deep attention to the details and a systematic approach to work.
Good knowledge of the clinical development process.
Good project management skills.
Excellent communication skills in both written and spoken English.
A clear demonstration of behaviors of truth seeking rather than success seeking.
Accepting peer review.
Desirable Skills/Experience
Ability to apply technical knowledge to problem solving.
Ability to proactively manage concurrent activities within role.
Understanding of other programming languages (e.g., SAS, R, Java, Groovy, Spotfire, C/C++, VBA/VBS, .NET, Python, Pearl).
Knowledge of industry standards (CDISC-CDASH/SDTM).
When we put unexpected teams in the same room, we unleash ambitious thinking with the power to encourage 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 are dedicated to pushing the boundaries of science to change the practice of medicine and transform the lives of patients living with cancer. Our innovative approach includes novel biomarkers, AI, novel endpoints, and ground breaking trial designs. By constantly innovating, we develop life-changing medicines that improve outcomes for patients everywhere. Our collaborative environment empowers team members to take smart risks, challenge norms, and learn from failures. Join us in our mission to eliminate cancer as a cause of death.
Ready to make a difference? Apply now!
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 authorisation and employment eligibility verification requirements.
