Required 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 6 years of experience in clinical trial database design and management, specifically with EDC systems such as Medidata Rave, including experience with Rave EDC Custom Function programming.
- Experience with clinical research and database development within the pharmaceutical industry, as we'll as Agile methodologies.
- Proficiency with database structures and programming languages.
- Expertise in eCRF design and specifications development.
- Experience writing, programming, or configuring data validation checks.
- Familiarity with QC, UAT, platform testing, and creating and executing test scripts.
- 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.
- Extensive experience with clinical data development, validation, execution, maintenance, and documentation, particularly for regulatory submission.
- Proven experience in leading system selection and implementation projects.
- Knowledge of systems outside of data management, such as safety systems, Clinical Trial Management Systems (CTMS), and electronic patient-reported outcome tools.
- Strong verbal and written communication skills, with the ability to collaborate effectively across multiple disciplines and regions.
- Extensive technical experience in developing scalable processes and solutions.
- 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 JReview and Business Objects.
Preferred Qualification:
- Knowledge of Visual Basic, SAS programming, or other object-oriented languages.
- Familiarity with other Medidata modules (eg, CTMS, RTSM, TSDV, Coder, Lab Admin) and their integrations.
- Understanding of relational databases and data capture standards (eg, 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.
Working Environment
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 Database Programming Lead/Manager works as part of a project team to design, implement and maintain Medidata Rave clinical databases and system used to collect, review and clean data in Astellas s phase 1-IV clinical trials.
- The Database Programming Lead/Manager 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:
- Leads and manages clinical database programming activities for multiple studies of varying complexity, adhering to established processes, standards, and timelines.
- Designs, develops, 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 complex technical issues, evaluating alternatives, and facilitating resolution.
- Creates, reviews, and approves technical specifications for data management systems, developing complex programs and technical solutions.
- Supports database build activities, including eCRFs, change requests, edit checks, custom functions, derivations, interface configuration, and migrations.
- Tracks issues in Medidata applications, collaborates with Medidata to resolve them, and escalates issues as needed to senior management.
- Assists with managing user access to clinical databases through iMedidata & Cloud Administration.
- Assists in the management and update of medical coding dictionaries, including MedDRA and WHODrug.
- Helps resolve data 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.
- Oversees 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.
