Clinical Data Configuration Specialist

**** Candidate should be good in R (Development) Language ****

Clinical Data Sciences (CDS)

Key to client success the Clinical Data Sciences team provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. The Clinical Data Sciences group is responsible for integrating structured and unstructured data across the various data sources, setup, data transfer/review and support downstream transformation and analysis.

The Clinical Data Sciences comprises of the Clinical Data Engineering and Clinical Data Standards. While the Clinical Data Standards provides the standards for clinical operation and data flow, the Clinical Data Engineering team drives the data architecture for clinical data. CDS also provides support to exploratory and specialty data for the purposes of data modelling, simulation, and analysis.

Clinical Data Configuration Specialist (CDCS), Clinical Data Sciences (CDS):

Key to client success is the Clinical Data Engineering team, provides strategic planning, integrating, execution, build and oversight of clinical trial deliverables. CDCS leads the integration of collected data from all sources by setting up proper configuration of data extraction and mapping of raw data into the Common Data Model for individual studies using processes and by the Data Engineer. Work with Data Engineer to configure (Extract Transform Load)ETLs and (Extract Load and Transform)ELTs. Provide testing and documentation for data pipelines. Utilize and contribute to libraries for functions and transformation templates for reuse for study level configuration tasks.

Key Accountabilities:

• Configure data extraction and transformations in an individual contributor role across multiple data sources at the study level as defined by the Data Transfer Agreement and other specifications provided by Data Engineer
• Partner closely with internal/external stakeholders and data engineers in a collaborative manner
• Ensure accurate delivery of data format and data frequency with quality deliverables per specification
• Participate in the development, maintenance and training rendered by standards and other functions on transfer specs and best practices used by business

Additional Activities:

• Assists with quality review of above activities performed by a vendor, as needed.
• Adhere to SOPs for computer system validation and all GCP (Good Clinical Practice) regulations.
• Ensure compliance with own Learning Curricula, corporate and/or GxP requirements. Performs other duties as assigned within timelines

Qualifications:

• Bachelor's degree plus 5 years /Masters with 3 years in computer science, statistics, biostatistics, mathematics, biology or other health related field or equivalent experience that provides the skills and knowledge necessary to perform the job.
• Experience with EDC build, Data Management, and EDC extraction configuration
• Knowledge of data flow between clinical data management systems, vendor devices and CDR.
• Knowledge of XMLS, ALS, APIs and MDR preferred.
• Experience with one of these languages: SQL, SAS, R, Python
• Understanding of SDTM
• Strong working knowledge of clinical trial terminology and data transfer specification expected
• Demonstrated ability to lead projects and work groups. Strong project management skills. Proven ability to resolve problems independently and collaboratively.
• Must be able to work in a fast-paced environment with demonstrated ability to juggle and prioritize multiple competing tasks and demands.
• Ability to work independently, take initiative and complete tasks to deadlines.

Special Skills/Abilities:

• Strong attention to detail, and organizational skills
• Good time management skills
• Quick learner and comfortable asking questions, learning new technologies and systems
• Good knowledge of office software (Microsoft Office).
• Experience with EDC build or data extraction configuration ETL/ELT experience
• Understanding of AWS/Data bricks concepts

Preferable but not required:

• Experience developing R shiny and Python apps
• Experience with Hadoop
• Experience with Agile development methods
• Experience with Veeva CDB

Supervision:

• Supervision required, should be able to function collaboratively (with guidance) with all levels of employees.

License/Certifications:

• Preferred to have SAS or R or Python certification,

Physical Demands:

• Ability to sit and stand for long periods of time.
• Carrying, handling, and reaching for objects.
• Manual dexterity to operate office equipment i.e. computers, phones, etc.