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 has built 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.

Position Overview

As a Senior Clinical Data Manager, you will play a key role in the execution of TrialSpark’s full study offering. We are looking for an experienced data manager who can help execute our Unified Data Layer strategy and deliver fast, high-quality data to support our studies. As part of your role, you’ll partner closely with other leaders across the company, contributing to TrialSpark’s broader Clinical Trial Engine strategy as well as contributing to process improvements and initiatives within the Biometrics area.

Duties and Responsibilities

Duties include but are not limited to: 

Key responsibilities will include:

• Create and/or review study-specific electronic Case Report Forms (eCRFs) using prior knowledge, protocol-specific information, and departmental standards. Work efficiently to incorporate core clinical team input and produce eCRFs in a timely manner.
• Configure, migrate, and test electronic data capture (EDC) databases based on internal procedures, study requirements, and system best practices. Serve as a database manager for the study-specific clinical team, including the compilation of edit checks.
• Develop database requirements for use by EDC vendors. Serve as a study database manager and work with vendors to obtain deliverables in a timely manner.
• Create and/or review study-specific data management and database documentation, which may include:
• Data Management Plan
• CRF Completion Guidelines
• Coding Guidelines
• Annotated CRFs
• Edit Check Requirements
• Attend study-specific team meetings and produce status reports and requested metrics, which may include query information or data trends.
• Perform data review and query generation/closure.
• Perform coding of verbatim terms such as adverse events and concomitant medications. Collaborate with medical scientists for coding, consistency, review, and approval
• Participate in the development of new processes or revision of existing processes
• Train Investigators and/or Study Coordinators at Investigator Meeting on the CRFs, the EDC system, and the CRF completion guidelines as needed.
• Provide data management expertise and support to the clinical teams using data management best practices
• Provide analytical insight on data management strategies and advise the internal team with tactical strategies accordingly

About you

Skills, abilities, and knowledge:

• Critical thinker with the ability to step back and rethink legacy assumptions in the clinical research space; should be able to point to what’s wrong, and how you would do it differently if starting from scratch
• Excellent cross-functional partnership skills; you know how to work across an organization to achieve objectives and meet timelines
• Superior written and oral communication skills; can synthesize complex concepts and deliver messages clearly
• MedDRA and Who Drug coding experience.
• Knowledge of CDISC/SDTM standards.
• Knowledge of GCP and other regulations

Education and Experience:

• 5-7 years of clinical data management experience
• Experience working with & building in EDC clinical databases; SAS/R programming experience a plus
• MedDRA and Who Drug coding experience 
• BS required, preferably in life sciences or a related field

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.