Database Programming ManagerAstellas Pharma • Bengaluru / Bangalore, India
Database Programming Manager
Astellas Pharma • Bengaluru / Bangalore, India
11 days ago
Job descriptionLead and manage study setup activities for multiple studies of varying complexity, adhering to established processes, standards, and timelines. Designs, develop specifications, and tests clinical databases, including forms, folders, matrices, data dictionaries, unit dictionaries, edit checks, derivations, and custom functions. Provides study-level support to teams and junior team members, assessing the protocol, evaluating alternatives, and facilitating resolution. Creates, reviews, and approves technical specifications for data management systems. Supports databases build specification development, including eCRFs, change requests, edit checks, custom functions, derivations, interface configuration, and migrations. Help resolve metadata anomalies and quality issues. Contributes to the creation of departmental documentation, such as training materials and process guides. Continuously seeks improvements in processes and templates to enhance operational efficiency. Oversee the activities of CRO vendors for outsourced data management systems, ensuring compliance with Astellas and industry best practices and timelines. Maintains regular communication with CRO staff, addressing questions, resolving issues, and mitigating risks. Provides expert-level technical guidance to junior team members, ensuring the delivery of high-quality results. Identifies and communicates lessons learned, best practices, and frequently asked questions. Maintains supporting documentation for studies and systems, ensuring quality, traceability, and compliance. Helps end users understand challenges and analyzes current processes to ensure context, implications, and expectations are clearly represented in the final solution. Bachelor's degree in computer science or a related field, with at least 8 years of experience in the pharmaceutical industry. A minimum of 4 years of experience in clinical trial database design and management, specifically with EDC systems such as Medidata Rave, including experience with Rave EDC Strong proficiency in protocol analysis and interpretation, with the ability to accurately transcribe eCRF specifications from protocol. Expertise in protocol schema mapping to database structures, ensuring accurate representation of study design elements such as arms, cohorts, visits, and endpoints. Expertise in eCRF design, specifications development, and Data Validation Specifications (DVS) to ensure accuracy, compliance, and operational efficiency. Deep understanding of therapeutic areas, including study objectives and endpoints. Expertise in primary and secondary endpoints, Schedule of Activities (SOA), and safety data requirements, ensuring accurate representation in database design and compliance with protocol specifications. Ability to manage screen review presentations, communicate effectively with cross-functional teams, and explain specifications prior to database build. Proven ability to lead technical discussions, provide strategic input on database design, and collaborate with clinical, data management, and programming teams. Skilled in stakeholder communication, including presenting complex technical concepts in a clear and concise manner. Proficiency in test case creation for CRF UAT, Data Flow UAT, and Edit Check UAT, ensuring thorough validation and compliance. Familiarity with QC, UAT, platform testing, and creating and executing test scripts. Strong verbal and written communication skills, with the ability to collaborate effectively across multiple disciplines and regions. Strong organizational skills and the ability to prioritize work to meet deadlines. Excellent interpersonal and project management skills, with the ability to collaborate effectively with individuals at all levels and from diverse backgrounds. Familiarity with other Medidata modules (e.g., CTMS, RTSM, TSDV, Coder, Lab Admin) and their integrations. Understanding of relational databases and data capture standards (e.g., CDSIC / CDASH). Advanced computer skills, including proficiency in MS Office (Word, PowerPoint, Excel, Outlook), with the ability to manage complex data analysis and pivot tables. Strong quantitative and analytical skills, with excellent critical thinking and problem-solving abilities. Ability to manage multiple technical projects and provide training to team members. Capacity to learn new technologies quickly and disseminate information effectively. Ability to innovate and transform current industry practices into more efficient solutions. Expertise in providing subject matter expertise, training, and mentoring to team members. Ability to lead discussions on best practices and facilitate input from team members. Ability to work independently and creatively within a collaborative, complex team environment. Experience in CRF Completion Instruction (CCI) document creation and maintenance. Proven ability to handle databases for complex protocols involving multiple cohorts, parts, or adaptive designs, including handling dynamic visit schedules and conditional logic. In-depth understanding of the Drug Development Process, Software Development Life Cycle, Computer Validation Process, FDA regulations, ICH-GCP, and other relevant Health Authority Guidelines. Solid understanding of database structures, programming languages, and integration of external data sources (e.g., IRT, RTSM, lab data, imaging, eCOA, safety systems). Experience with Agile methodologies in clinical research and database development. Ability to identify and mitigate risks in database design and implementation. Experience in managing studies across multiple regions and therapeutic areas. Experience in writing, programming, or configuring data validation checks.
Astellas' Global Capability Centres (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are located in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands.
Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company's strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
Purpose And Scope
- The Technical Designer (TD) works as part of a project team to develop specification requirements, implement and maintain Medidata Rave clinical databases and system used to collect, review and clean data in Astellas's phase 1-IV clinical trials.
- To translate functional requirements into detailed technical specifications that database programmers can implement.
- Ensure technical feasibility, scalability, and alignment with organization level standards.
- Act as a liaison between Database Programmers, Data Managers and clinical teams ensuring clarity and consistency.
- The Technical Designer (TD) will actively search for solutions which reduce set-up times including increased automation of the set-up and will take a leading role in evaluation or improvement projects regarding data management applications or interfaces between data management systems and other applications.
- Development and improvement of standards, templates, and process to improve efficiency and quality of databases / database set-up is expected along with a level of technical expertise that evokes innovation.
Technical
Responsibilities and Accountabilities :
Quantitative Dimensions : Oversees the development and maintenance of 18-20 studies per year.
Required Qualifications
Preferred Qualification
Category Quantitative Sciences & Evidence Generation
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability / Protected Veterans
Skills Required
Test Case Creation, protocol analysis
Create a job alert for this search
Database Programming Manager • Bengaluru / Bangalore, India
Similar jobs
Senior Database Engineer
Shell Recharge Solutions • bangalore, karnataka, in
Shell Recharge Solutions is seeking a.The ideal candidate is an integral part of a fast-paced development team that builds an integrated product suite of Enterprise applications in the EV Charging ...Show more
Last updated: 7 days ago • Promoted
Database Architect
ACL Digital • bangalore, karnataka, in
Research vulnerabilities, CVEs, patches across RDBMS, NoSQL and Big Data platforms.Analyze traffic patterns and commands to identify attack vectors.
Design and deploy real-time security policies and...Show more
Last updated: 1 hour ago • Promoted • New!
Manager, Database Engineering
BlackLine India • Bengaluru / Bangalore, India
It's fun to work in a company where people truly believe in what they're doing!.At BlackLine, we're committed to bringing passion and customer focus to the business of enterprise applications.Since...Show more
Last updated: 11 days ago • Promoted
Senior Database Automation Engineer
Zyoin Group • bangalore, karnataka, in
Senior Oracle Database Automation Engineer.Multi-Cloud / Platform Engineering.Senior Oracle Database Automation Engineer.
Oracle database provisioning, backup, recovery, and high-availability across...Show more
Last updated: 4 days ago • Promoted
SingleStore Database Administrator / Engineer
Genpact • bangalore, karnataka, in
SingleStore Database Administrator / Engineer.The team encourages open communication, new technologies and thinking out of box.
Database Management : Install, configure, and maintain SingleStore data...Show more
Last updated: 25 days ago • Promoted
Database Administrator
BNP Paribas • bangalore, karnataka, in
Sybase Database Administrator (L3).This position is for a senior Database Administrator - Sybase to provide technical support to the Local and Regional Database Environments.We are seeking a hands-...Show more
Last updated: 15 days ago • Promoted
Configuration Management Database Professional (CMDB)
Unisys • Bengaluru / Bangalore, India
What Success Looks Like In This Role.Lead or participate in special projects related to asset management, such as system upgrades, process reengineering, or strategic initiatives.Should be ITILV4 &...Show more
Last updated: 11 days ago • Promoted
Progress DBA
Tata Consultancy Services • bangalore, karnataka, in
Competent in OE V10 & OE V11 Skills as mentioned below.Proficient in OE installation and configuration.Good Working experience on Migration of Openedge from OE10 to OE11.
Well versed with Unix shell...Show more
Last updated: 1 day ago • Promoted
HCL Now CloudOps Product _Sr. Database Administrator (Maria DB)
HCLSoftware • bangalore, karnataka, in
Greetings from \"HCL Software\".Product Development Division of HCL Tech : That operates its primary Software business.At HCL Software we Develop, Market, Sell and Support over 20 Product families i...Show more
Last updated: 14 days ago • Promoted
Database Engineer
Talent500 • bangalore, karnataka, in
This is an Full-Time opportunit with a Product based company called.Routeware builds software that powers the daily operations of waste and recycling.
Our products sit at the intersection of logisti...Show more
Last updated: 30+ days ago • Promoted
Database Administrator
TRDFIN Support Services Pvt Ltd • bangalore, karnataka, in
We are hiring a senior Database Administrator (L3) to manage large scale Oracle and Microsoft SQL Server environments.The role focuses on performance optimization, migration projects, high availabi...Show more
Last updated: 11 days ago • Promoted
Cloud Database Adminstrator
ALIANDO • bangalore, karnataka, in
Job Title : Cloud Database Administrator.ALIANDO is an award-winning Azure Expert Managed Service solutions company focused on selling and deploying Microsoft technologies for U.For over 20 years, M...Show more
Last updated: 30+ days ago • Promoted
Senior Oracle Exadata DBA
Centrilogic • bangalore, karnataka, in
Senior Oracle Exadata DBA – Advisory Services.As part of the Advisory Services organization, the role of the Senior Oracle Exadata Database Administrator will be responsible for the implementation,...Show more
Last updated: 25 days ago • Promoted
Senior Database Architect
Infosys Finacle • bangalore, karnataka, in
Job Description : Senior Database Architect (PostgreSQL / Oracle) – 10+ Years Experience-JL6.We are seeking a results-driven Senior Database Architect with 10–20 years of hands-on experience in managi...Show more
Last updated: 20 days ago • Promoted
Principal - Database Product Architect
Oracle • bangalore district, karnataka, in
Oracle and multi-cloud database products across on-premises, OCI, AWS, Azure, and GCP.Translate business and customer requirements into.
GoldenGate, Data Guard, RMAN, ASM, ZDM, and snapshot standby ...Show more
Last updated: 4 days ago • Promoted
Manager, Database Engineering
BlackLine • Bengaluru / Bangalore, India
It's fun to work in a company where people truly believe in what they're doing!.At BlackLine, we're committed to bringing passion and customer focus to the business of enterprise applications.Since...Show more
Last updated: 18 hours ago • Promoted • New!
Sybase DBA SME
Voya India • bangalore, karnataka, in
Years of Experience - 11 to 15yrs.Provide 24 / 7 support for critical systems, troubleshooting issues and collaborating with application teams.
Hands-on experience in installing, configuring, and mana...Show more
Last updated: 7 days ago • Promoted
Databricks Architect
Persistent Systems • bangalore, karnataka, in
Were looking for an Database Architect to drive the strategy and implementation of a centralized mapping data factory using Databricks as the transformation engine, enabling self-service, governed,...Show more
Last updated: 16 days ago • Promoted