Clinical Systems Developer

About TrialSpark

TrialSpark is a technology-driven drug development company that runs end-to-end clinical trials, focused on bringing new treatments to patients faster and more efficiently.

The biggest bottleneck in bringing new treatments to patients is the clinical trial. On average, getting a drug through the trial process takes nearly a decade and frequently costs $1B+. To combat this industry problem, TrialSpark is building a technology platform that optimizes all aspects of a clinical trial, enabling more efficient trial design, faster trial completion, and higher trial data quality.

TrialSpark recently raised their Series C, and is putting the capital to work by  in-licensing and co-developing drug programs through in-house development, joint ventures, and NewCos. Together with doctors, patients, and communities, TrialSpark is working to develop the treatments of tomorrow.

About the Position

As the Clinical Systems Developer you will be responsible for analyzing, designing, developing, implementing, supporting and enhancing clinical data systems.

Responsibilities

• Execute configuration, testing, and validation responsibilities related to the setup and management of clinical data systems for one or more trials of low to high complexity.
• Create summaries, reports, and documentation, as well as provide insights into the validation process to ensure project deliverables and timelines are met in collaboration with internal team, Data Management, Programming, and Clinical Operations.
• Collaborate cross-functionally to understand the purpose of data collected and define trial level requirements related to clinical data systems.
• Ensure correct adoption of clinical data standards to guarantee consistency across studies, compounds, disease areas, and therapeutic areas.
• Provide oversight on external solution vendors performing data collection activities and assist in the execution of data management activities internally.
• Perform study database design and build programming activities.
• Actively contribute to the shaping of the technical layout of the Operations department by partnering with Product & Engineering to develop new system features, improve existing system functionality, and assist in testing and validation activities.
• Other incidental duties.

About You 

• Bachelor’s degree in Health Sciences, Clinical Data Management, Nursing or other relevant scientific field, or equivalent work experience is required.
• 3+ years relevant experience within the Pharmaceutical, CRO or Biotech industry, or equivalent is required.
• Experience working in a multi-functional environment and ability to adapt to different ways of working and development methodologies is required.
• Proven track record of effective communication skills, including strong verbal and written communication, influencing, and partnering skills is required.
• Demonstrated experience working with industry leading clinical data capture tools (e.g., Rave, Veeva, InForm, Merge) and related integrations (e.g., Safety Database, Coding, IXRS, external platforms) is required. Experience working with DCT, device, and/or sensor vendors is a plus.
• Ability to review protocol & associated study documentation and translate into clinical data system functional & user requirements is required.
• Solid understanding of the overall drug development process and GCP/ICH guidelines is required.
• Advanced technical expertise in EDC systems (e.g., certified study builder, standards and library management, integration support) is a plus.
• Demonstrated understanding of relevant data collection and submission industry standards (e.g., CDASH, SDTM) is preferred.
• Programming experience in SAS, R, SQL, or C++ is preferred, but not required.

You will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.