Principal Database Developer

How will you make an impact?

The Principal Clinical Programmer will oversee multiple clinical trial programs, designing study databases, programming edit checks, integrating external data sources, and modeling and delivering data reports, dashboards and datasets, including resourcing to ensure timely high-quality deliveries. The Principal Clinical Programmer will also serve as a mentor for junior team members. Where required, the Principal Clinical Programmer will lead individual programs. In partnership with the Data Management, Biostatistics, and Clinical Operations teams, the Principal Clinical Programmer will develop standard operating processes in support of Clinical Research, identifying, implementing and owning clearly communicated standards for the creation of repeatable, efficient, industry-leading work product.

What will you do?

• Clinical Programming Team Resourcing and Company’s Business Objectives:
  Oversee resourcing needed to support clinical programming activities on multiple clinical studies. 
• Develop and execute on clinical programming goals to support the Company’s Business Objectives and principles.

Database Design and Programming:

• Oversee the development of study database designs (e.g. electronic Case Report Forms) for multiple clinical trial programs, modelling design on CDISC standards. 
• Oversee (including lead, as needed) the implementation of data cleaning strategies (e.g. edit checks, reports, etc.) in accordance to Edit Check Specifications,Data Management Plan, and Data Review Guideline for multiple clinical trial programs
• Oversee (including lead, as needed) the timely delivery of a quality locked database for analyses at the close of studies.
• Oversee (including lead, as needed) clinical programming deliverable activities and timelines (e.g., EDC, Edit Checks, Reports, Dashboards, SDTM datasets, etc.) for multiple studies. Lead computer system validation activities.
• Oversee the identification, information gathering, requirements document development and system validation of external technologies.

Collaboration with Cross-Functional Teams and other Clinical Programmers:

• Collaborate with internal team and stakeholders to ensure deliverables meet timelines.Collaborate with other Clinical Programmers to identify and initiate discussions with EDC providers on requested system functionality / configurability updates.
• Collaborate with other Clinical Programmers on reviewing EDC system updates for impact on current builds and identify mitigating actions and testing as needed.
• Oversee the ongoing day to day support to Data Managers and Clinical Study Teams to ensure all systems and programs are executing correctly and efficiently, to include validating/checking programming.
• Present on clinical programming topics at in-house meetings/trainings. 

Process Improvement:

• Lead the standardization of libraries for CRFs (modelling CDISC standards) and edit checks to expedite study deliverables.
• Lead the recommendations and implementations of technical and process solutions that can be used of developed to increase efficiency of project work.
• Stay current with industry trends and emerging technologies in clinical programming.
• Conduct regular reviews of clinical programming activities to maintain high-quality stand-ards
   

Vendor Management:

• Coordinate and manage relationships with external vendors providing data management services.
• Oversee the selection, qualification, and performance of third-party vendors.
• Oversee the Management of service providers (e.g., Labs, Medical Coders) to ensure agreed upon performance on quality and timeliness of deliverables.
• Oversee (including lead, as needed) the creation of Data Transfer Agreements and manage delivery of third-party clinical data for reconciliation and cleaning.

How will you get here?

• Minimum of 12 years of experience working in Pharmaceutical/ Medical Device/ Biotechnology/ CRO industry in Clinical Programming or related functional area required.
• Understanding of FDA/ICH guidelines and industry/technology standard practices.
• Experience with any EDC systems platforms (e.g. MedNet, Rave, Veeva Vault EDC etc.).
• Deep and broad clinical programming experience in the life sciences industry (e.g. Device, Biopharmaceutical, Biotech, CRO companies.
• Experience with Data Visualization, Reporting or Visual Analytics tools  
• Demonstrated depth of understanding of the clinical trial process. 
• Experience extracting and transforming clinical data to support Reporting & Analytics. 
• Demonstrated multi-tasking, problem-solving and verbal and written communication skills essential.

Generous.