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eCOA Build Programmer-1

ConfidentialBengaluru / Bangalore

30+ days ago

Job description

The electronic Clinical Outcomes Assessment (eCOA) Build Programmer is responsible for designing, programming and testing clinical trial data collection databases, including the mapping, testing and normalization of data into a clinical data warehouse. This requires an in depth understanding of data technology, data flow, data standards, database programming, normalization and testing. This role will collaborate with Data and Analytics colleagues such as the Clinical Data Associate, Clinical Data Manager, Statistician and other key partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials.

Responsibilities : Portfolio Delivery :

Gather and influence eCOA design specifications to enable successful trial implementation
Program and test data collection systems and associated data repository mappings for a trial or set of trials within a program using data standards library components
Ensure data collection systems and data warehouse mappings are delivered accurately, efficiently and in alignment with study objectives
Partner with translation vendors to implement localized data collection
Partner with Clinical Build Programmer to ensure complete data build for trial data collection needs
Provide insights into study level deliverables (ie Data Management Plan, Project Plan, database, and observed datasets)
Support submission, inspection and regulatory response activities
Lead cross Business Unit / Therapeutic Area projects or programs with high complexity
Opportunity to develop and tests new ideas and / or applies innovative solutions that add new value to the portfolio

Project Management :

Increase speed, accuracy, and consistency in the development of systems solutions

Enable metrics reporting of study development timelines and pre and postproduction changes to database

Partner to deliver study database per business need and before first patient visit

Follow and influence data standard decisions and strategies for a study and / or program

Utilize therapeutic knowledge and possess a deep understanding of the technology used to collect clinical trial data

Effectively apply knowledge of applicable internal, external and regulatory requirements / expectations (MQA, CSQ, MHRA, FDA, ICH, GCP, PhRMA, Privacy knowledge, etc) to study build deliverables

Integrates multi-functional and / or external information and applies technical knowledge to data-driven decision making

Enterprise Leadership :

Continually seek and implement means of improving processes to reduce study build cycle time, decrease work effort and enable the normalization of various sources of data into a common data repository in a way that allows for improved integration, consumption and downstream analysis

Represent Data and Analytics processes in multi-functional initiatives

Actively engage in shared learning across Data and Analytics organization

Work to Increase re-usability of screens and edits by improving the initial design

Work to reduce postproduction changes change control process

Anticipate and resolve key technical, operational or business problems that impact the Data and Analytics organization

Interacts with regulators, business partners and outside stakeholders on business issues

Thinks with end to end in mind consistently managing risk to minimize impact on delivery

Builds a diverse multi-functional and internal / external network to understand how different disciplines and approaches contribute to research and development

Focuses on defining database solutions and timelines in support of advancing the portfolio

Basic Qualifications :

bachelors degree in computer science, engineering, medical field, Informatics, Life Sciences, ,

Statistics, Information Technology, with 3 or more years of hands-on experience in database programming, or a combination of clinical data management, system validation and data analysis, experience in the clinical, pharmaceutical, biotech, CRO or regulatory agency sectors

Additional Preferences :

Masters degree in computer science, engineering, medical field, Informatics, Life Sciences, , Statistics, Information Technology or a related analytics discipline

Quick learner to new trends in technology

Excellent leadership, communication (written and oral) and interpersonal skills

Demonstrated leadership in professional setting

Demonstrated teamwork and collaboration in a professional setting

eCOA, eSource or Direct Data Capture implementation

Data analytics and visualizations

Articulating the flow of data (structure and format) from patient to analysis and apply this knowledge to data solutions

Deciding the technology platform (system / database) for data acquisition and aggregation

Utilization of clinical / drug development knowledge and an ability to liaise effectively with study team members (ie Data Sciences, Statistics, PK, Operations, Medical)

Strong therapeutic / scientific knowledge in the field of research

Project management experience

Vendor management experience

Familiarity with clinical data tools and technologies

Understanding and experience in using data standards

Knowledge of medical terminology

Ability to balance multiple activities, prioritize and manage ambiguity

Demonstrated exemplary teamwork / interpersonal skills

Proven problem solving, attention to detail and result oriented behaviors in a fast-paced

Role : Software Development - Other

Industry Type : Pharmaceutical & Life Sciences

Department : Engineering - Software & QA

Employment Type : Full Time, Permanent

Role Category : Software Development

Education

UG : Any Graduate

PG : Any Postgraduate

Skills Required

Cro, Data Analysis, Project Management, Data Collection

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Build • Bengaluru / Bangalore