Astellas Pharma

Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong to Astellas!Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.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.Responsibilities and Accountabilities:Technical:• Lead 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.Quantitative Dimensions: Oversees the development and maintenance of 18-20 studies per year.Location(s)Bengaluru, IndiaRequirementsRequired Qualifications:• 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.Preferred Qualification:• 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.

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