Head of Clinical Data Management
Head of Clinical Data Management
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 technology company that brings new medical treatments to patients faster. We’re reimagining the clinical trial by introducing a new model, using technology to streamline every aspect of the trial. To fulfill our mission, we partner with pharma, biotech, and digital health companies to run studies faster and more efficiently.
About the position
As Head of Clinical Data Management, you will be responsible for leading TrialSpark’s Clinical Data Management organization, driving the team’s strategy, capabilities, systems, and deliverables. We’re looking for an experienced Clinical Data Management leader, who can leverage their experience and expertise to reimagine data management from the ground up, leveraging new technology and more efficient processes to deliver faster and higher quality clinical trial data. As TrialSpark is developing its own in-house EDC platform, a core component of this role will be partnering with our technology team on its design and implementation. Additionally, as a core member of TrialSpark’s operations leadership team, you will also partner closely with other leaders across the company, contributing to TrialSpark’s broader CRO strategy and build out. This is a high profile and high impact role within TrialSpark, and represents a unique opportunity to rethink what Clinical Data Management looks like at a modern, technology-forward clinical trials company.
Key responsibilities will include:
- Using industry knowledge, experience, and first-principles thinking to drive TrialSpark’s Data Management strategy.
- Building out and managing the Clinical Data Management team at TrialSpark, including Data Managers, Database Builders, Medical Coders and Programmers
- Leading clinical data strategy across our portfolio of studies, ensuring the Data Management team delivers against time, quality and cost targets.
- Partnering with the product and engineering teams to develop Data Management workflows within our internal technology products.
- Working closely with cross-functional teams from Operations, Medical, Engineering, QA, and more to advance TrialSpark’s broader CRO capabilities.
- Represent Data Management capabilities to study sponsors, including participating in bid defenses.
- Lend industry expertise across TrialSpark, helping us plot our route toward making clinical trials faster, more efficient, and higher quality.
Skills, Abilities, and Expertise
- A demonstrated ability to lead Data Management strategy.
- Deep experience in developing and executing DMPs across complex global clinical trials.
- A track record of building and leading high performing Data Management teams.
- Thorough knowledge and understanding of clinical research concepts, practices, and regulations.
- Expertise in clinical technology landscape including regulations on software in clinical research
- Critical thinker with 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.
- Solid written and oral communication skills; can 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 preferred
- Located in the greater New York metro area or willing to relocate.