Senior Clinical Database Developer

2 weeks ago

Bengaluru, India George Clinical Full time
We are expanding We have many new ground-breaking global clinical trial projects in various phases and therapeutic areas across the globe and want your ideas and expertise to help us build and grow.

Who are we?A leading global clinical research organization founded in Asia-Pacific driven by scientific expertise and operational excellence20+ years of experience, ~500 people managing 39+ geographical locations throughout the Asia-Pacific region, USA, and EuropeFull range of clinical trial services to biopharmaceutical, medical device, and diagnostic customers, for all trial phases, registration and post-marketing trialWe combine scientific leadership and global operational excellence, with strong experience in renal medicine, oncology, cardiovascular and chronic diseases across various phases to improve the health of millions worldwide.

Why work with us?We are a global team making a difference in the world – our clinical trials improve the health of millions worldwideCompetitive salary and benefitsFlexible and agile working arrangements - onsite, hybrid or WFH (dependent on location)Strong and diverse Learning & Development opportunities including exposure to all aspects of clinical trials with an unparalleled network of Scientific Leaders to learn fromA focus on employee wellbeing including global employee engagement surveys, steps challenges, reward and recognition programs, team building activities and other fun events

About the role:The Senior Clinical Database Developer is responsible for independently developing the clinical databases in the Electronic Data Capture (EDC) systems including programming of edit checks/rule/dynamics/alerts etc. in support of George Clinical (GC) research projects to ensure the collection of complete and accurate data for final analysis. The SCDD role is expected to demonstrate excellent technical skills concerning the usage of EDC systems, strong analytical skills, excellent attention to detail, and communication skills.

Key Accountabilities:Act as the Lead DB Developer (DBD) for the allocated studies by being the primary POC where the responsibilities include but are not limited toParticipate in the KOM/review protocols and draw plans to develop databases independentlyActively liaise with the stakeholders (external and internal) to determine study requirements, deliverables and timelinesBuild eCRF screens as required by the schedule of events in the protocol.Program advanced level edit checks, custom functions dynamics and setup rules and alerts as per the Edit Check Specifications (ECS)Setup specific functionalities such as Randomisation and Trial Supply Management (RTSM), Coding, Data Migrator etc. as necessaryContribute to the development of Database Specifications and ECSDemonstrate ability to make study DBs live on time to the satisfaction of all stakeholdersPerform user and site management and maintain active users listDevelop reports to assist cross functional teams/sites/Other as necessaryAchieve Mid Study Updates (MSU) when necessary to the satisfaction of stakeholders, by performing the impact analysis and making updates in the databaseContribute to the process of external data integration when necessary (IWRS/Safety DB/ECG/Laboratory/Other)Develop Non-CRF Data Specifications, RTSM Specification/Guidelines when necessaryPerform database lock (interim/final) in consultation with PDD and other stakeholders by tracking the study progress and ensuring the necessary steps are complete for DB lockDemonstrate ability to quickly learn and work with new EDC tools when necessaryEffective communications with cross-functional project teams

What are our expectations of candidates?Tertiary qualifications in Technical/Clinical Research or a related fieldExperience of minimum three EDC tools, for instance RAVE, Merative Zelta, Medrio, Oracle Clinical or other web-based data capture tools is preferable.Experience of a minimum of 10 years of DB development experience demonstrating strong technical skills, building complex clinical databases out of which three years as lead DB developerMinimum 8 years’ experience in the CRO/Pharma environment and 5 years as a Database DeveloperKnowledge of Good Clinical Practice (GCP) and applicable regulatory guidelines, especially as related to data handling and processingAbility to evaluate and recommend changes to existing processes and procedures for greater effectiveness

We are searching for individuals who are excited by the idea of regional and global projects and teams, don’t want to get lost in a large CRO and are ready to have their ideas heardYou will be willing to extend yourself and take on new challenges while living our values of Mutuality, Integrity, Can-do approach, Empowerment and Excellence.

How do I apply and what if I'm interested in a role in future or want to refer someone?Apply via LinkedIn or send your CV, referral or confidential query

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and our friendly HR team across the world will reach out as appropriate soon. Please provide your full contact details, the location you are applying for, whether you are interested in a current or future opportunity and we'll be in touch. We are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.

How do I learn more about the roles and George Clinical?Follow us on Linkedin to see our regular updates and how we celebrate our people and success across our business and projects You can also visit us atWe are reviewing applications as we receive them but please note that only short-listed applicants will be contacted.

Thank you for your interest in working with George Clinical. As a global business, we are committed to handling Personal Information in accordance with applicable privacy and data protection laws in the many countries in which we do business. Please see our Privacy Policy for further information.

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