Director, Clinical Data Management
- Hoboken, NJ
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+. And the problem is only getting worse.
TrialSpark is a new healthcare company that owns the end-to-end drug development process. Our proprietary technology allows us to integrate and improve clinical research for patients, providers, and sponsors, while executing clinical trials faster and cheaper.
About the position
The Director of Clinical Data Management (CDM) is responsible for leading TrialSpark’s Clinical Data Management organization, driving the team’s strategy, capabilities, systems, and deliverables. The Director of CDM is responsible for leveraging new technology and efficient processes to deliver clinical trial data to stakeholders rapidly. The Director of CDM plays a key role in partnering with the technology team on the design and implementation of the proprietary, in-house electronic data capture (EDC) system Additionally, as a core member of TrialSpark’s operations leadership team, the Director of CDM partners closely with other leaders across the company, contributing to TrialSpark’s broader CRO strategy and build-out.
Key responsibilities will include:
- Using industry knowledge, experience, and first-principles thinking to drive TrialSpark’s Data Management strategy.
- Builds out and manages the Clinical Data Management team at TrialSpark, including, but not limited to, Clinical Data Managers, Database Builders, Medical Coders, and Programmers
- Leading clinical data strategy across the complete portfolio of studies, ensuring the Data Management team consistently delivers against time, quality and cost targets.
- Partnering with the Product and Engineering teams in the definition of system requirements for internal technology products including eSource, ePRO, and EDC systems.
- Partnering with the vendor management, product, engineering, and other teams to develop Data Management workflows to integrate data within the internal and external technology products.
- Works closely with cross-functional teams from Operations, Medical, Engineering, QA, and more to advance TrialSpark’s broader CRO capabilities.
- Lending industry expertise across TrialSpark, helping us plot our route toward making clinical trials faster, more efficient, and higher quality.
- Representing Data Management capabilities to study sponsors, including participating in bid defenses.
- Demonstrated ability to lead Data Management strategy and a Data Management business unit.
- Deep experience in developing and executing all required controlled documents across complex global clinical trials.
- A track record of building and leading high performing Data Management teams.
- Thorough knowledge and understanding of 21 CFR, Part 11, International Council of Harmonization E6(R2), Good Clinical Data Management Practice (GCDMP), and applicable federal and international regulations and guidance.
- Expertise in the clinical technology landscape including software and digital systems used in clinical research.
- Critical thinking skills with the ability to rethink legacy assumptions in the clinical research space and develop efficiencies wherever possible..
- Cross-functional partnership skills and the ability to work across an organization’s functional groups to achieve objectives and meet timelines.
- Solid written and oral communication skills with the ability to synthesize complex concepts and deliver messages clearly.
Education and Experience
- 7+ years of Data Management experience at a sponsor or CRO
- 4+ years leading Data Management teams
- BS required, preferably in life sciences or a related field
- CCDM certified or GCDMP expertise preferred
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.
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