JOB SUMMARY

The Data Manager and Programmer provide comprehensive data service expertise and efficient quality data management services that meet sponsor, CROs, and vendor needs. The Data Manager and Programmer builds applications to enhance and facility the data cleaning process at Clinilabs. The position has a high-level of interaction with Clinilabs Corelab and CDM Teams to design, develop and verify data management applications utilized to meet Clinilabs and Vendor’s Quality Control requirements for clinical data. The Data Manager and Programmer interacts heavily with sponsors, CROs and vendors to discuss and define Data Transfer Specifications Agreements for clinical studies.

RESPONSIBILITIES

• Develop data management applications and tools to support Clinilabs, Sponsors, CROs and Vendors, Quality Control and Edit Check requirements for clinical data.
• Provide support and act as the Data Management point person to the Sponsor, CROs, vendors, clinical sites, project managers and scorers.
• Responsible to develop Data Transfer Specification Agreements in collaboration with Sponsors, CROs and Vendors.
• Develop and maintain good communications and working relationships with Clinilabs project team members as well as Sponsor, CRO, vendor, and clinical site project team members.
• Assist in the design, development and execution of study user acceptance testing (UAT) for clinical studies.
• Responsible to develop, execute, and maintain Software/System Application(s) validation and change control in adherence with company’s SDLC and validation policy.
• Provide data QC training to data services team.
• Perform data analysis and verification functions for assigned clinical studies; transfer cleaned data to Sponsors, CROs and Vendors.
• Responsible to serve as technical resource for internal and external support requests related to Corelab systems ensuring rapid and timely resolution.
• Follow and ensure compliance with current Good Clinical Practices (cGCPs).
• Ensure data services software/application compliance with 21 CRF part 11.
• Adhere to corporate policies and procedures.
• Other duties as assigned.

TRAVELING

Between the Corporate New York site and the New Jersey sites, as needed.

  The salary for this role is up to $75,000, and it may vary depending on your location and experience. 

• The position requires at least a bachelor’s degree in Computer Science, Mathematics or related field with a minimum of 2 years of experience working with SAS or relevant statistical programming in clinical trials.
• Strong understanding of data collection, data flow management, data quality, data extraction and data standards (knowledge of CDISC standards for CDASH, SDTM, and ADAM is a plus).
• Experience with multiple programming languages (SAS, R, Python, MS SQL or other languages/tools as required), SAS Certification preferred, including the creation of data entry and query screens/processes and data quality checks.
• Experience developing data reports and data cleaning programs, especially for data validation and quality assessment; experience with building GUIs and APIs for data processing, data integrity checks, and data mining.
• Experience in management and programming Electronic Data Capture system(s).
• Experience in developing custom reports to support clinical development.
• Strong attention to detail and demonstrated proficiency in quantitative and qualitative analysis.
• Ability to manage multiple projects, tasks, and priorities; work independently with minimal supervision and execute tasks to completion without a great deal of direction.
• Experience in training users in operation of clinical trials software and tools.
• Good oral and written communication skills, demonstrated strong teamwork, organizational skills and time management.
• Comprehensive knowledge of software development life cycle processes and software validation. Experience performing software application validation and change control.
• Good Clinical Practices training.
• Excellent computer, organizational, and communication skills.