Highline Sciences is a specialized, full-service CRO and consultancy founded from within an oncology biotech to provide a better solution for innovative biotech companies. We are purposefully a different type of CRO. We aim to recruit, develop, and retain industry super stars that are curious, passionate, and want to make a difference. We’re looking for people who share our vision and want to contribute their unique skills and experience to a shared mission.

Summary:

Responsible for delivering quality EDC trial configurations for clients leveraging Medidata Rave platform. You will perform configuration for the EDC projects and building those studies in the Rave platform. In addition, as the Database Programmer you will perform Quality Control of configured projects for activities that you did not perform the development/configuration. You will also provide consulting services that may include user acceptance testing (UAT) of EDC systems, global library/standards development, and report quality control.

Job Responsibilities:

• Assists with database design or modifications to solve database processing problems considering computer equipment capacity and limitations, operating time, and form of desired results.
• Performs the administration, monitoring, tuning and support of databases in the production environment.
• Design specifications of EDC Trial Build services for core configuration, eCRFs, data validations (DVS) and reporting
• Develop configuration of the EDC trial by utilizing the trial design specifications for eCRFs, DVS, custom functions integrations and reporting
• Advise clients on best practices for clinical database builds, eCRF layout and compliance with CDISC standards.
• Implement and perform data integrations related activities to ensure data integrations meet client requirements.
• Collaborate with the project team to ensure data can be extracted easily from the back end to support efficient downstream reporting and analysis.
• Collaborate with the project team to ensure the configuration is completed on time with high quality.
• Provide Quality Control on deliverables developed by other team members.
• Maintain all required Configuration Specifications and Quality Control documents as required by SOP and Processes
• Collaborate with training team as an EDC Subject Matter Expert and perform training.
• Work on consulting efforts related to EDC systems including UAT, global library/standards development.
• Ensure compliance with industry quality standards, regulations, guidelines, and procedures.
• Implements database setups of development, user acceptance test and production environments.
• Implements backups and recovery procedures.
• May participate in database analysis and database design tasks to meet required operational standards and performance levels (as measured by reliability, response time, query execution time, etc.).
• May participate in database consultations and database design reviews.
• Develop and maintain good communications and working relationships with teams and external clients.
• Conducts review of project deliverables, ensuring that output meets expectations and is consistent with analysis described in study documents.
• Work collaboratively with other departments to optimize cross department functionality.
• Establish and maintain positive relationships with industry clients that foster confidence and facilitate problem resolution.
• May participate in or lead departmental or corporate initiatives.
• Performs other work-related duties as assigned.
• Minimal travel may be required.

Demonstration of Highline Values:

Consistently strives to demonstrate the following Highline Sciences values:

• Recognizes that the team is always stronger than the individual.
• Seeks to inspire others by demonstrating consistently strong performance.
• Treats people with respect regardless of role or point of view
• Listens well and seek to understand before reacting.
• Provides candid, helpful, and timely feedback to colleagues.
• Demonstrates curiosity about and contributes effectively to areas outside of their specialty.
• Keeps the bigger picture in mind when making decisions.
• Never stops learning.
• Questions assumptions and offers suggestions for improvement.
• Focuses on results rather than process and seeks to minimize complexity when process is required.
• Identifies and addresses root causes, not symptoms.
• Demonstrates poise in stressful situations.
• Strives to always do the right thing.
• Questions actions that are incongruent with Highline Sciences values

Minimum Qualifications:

• Bachelor’s degree preferred, analytic discipline a plus (Computer Science or Health related field) and/or equivalent work experience.
• 7+ years in CRO/Pharmaceutical/Biotechnology industry
• Experience with requirements gathering, design and specification development of eCRFs, edit checks, and understanding of database structures and programming languages.
• Knowledge of ICH/GCP guidelines, 21 CFR Part 11, clinical trial methodology, software development lifecycle activities and CDISC standards (CDASH, SDTM)
• 5+ years’ experience working with Medidata Rave platform.
• Custom Functions programming experience using C#.
• Oncology clinical trials or oncology clinical experience
• Excellent written and verbal communication skills.
• Excellent organizational skills, attention to detail and ability to handle multiple competing and changing priorities within tight timelines.
• Able to proactively anticipate needs and follow through on all assigned tasks.
• Proficient in Microsoft Word and Excel

Preferred Qualifications:

• Experience with Database programming is a plus: SQL Server
• Familiarity with EDC Systems: InForm or Oracle Clinical
• Experience with Business Intelligence Tools: Business Objects, JReview, Cognos, or related.
• Early phase clinical trial experience

Our core belief is that it’s all about the team.

More specifically, bringing great people together to deliver incredible outcomes. With this approach, we are a more flexible, collaborative, innovative, inspiring and successful organization. We also happen to have a lot of fun.

We believe in questioning the norm and looking for alternatives. We seek out team members who are driven by curiosity and understand the power of the collective. We encourage continual learning and constructive feedback. We strive to build and maintain trust, both internally and externally.

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