Validation Manager
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.
About the Position
TrialSpark is looking for a Validation Manager. This role will work with our Engineering, Product, and Quality Assurance (TrialSpark's regulatory compliance function) teams to ensure the software we ship to production meets regulatory expectations. They will be responsible for test script creation, execution, and requirements documentation of both internally built and vendor systems.
Responsibilities
- Writing, executing, and refining manual test scripts used to validate TrialSpark-developed systems.
- Integrating with existing agile software development life cycle to report defects found during testing and verify fixes.
- Supporting and assisting Computer Systems Validation process for internal and external systems.
- Assisting in writing and updating documentation (validation plans, traceability matrix, risk assessment, change control, testing protocols, etc.) for compliance purposes.
- Working with product managers and engineers to develop test plans and to execute them in a timely fashion.
- Helping oversee day-to-day testing activities and coordinating with internal compliance team members.
About You
- Knowledge of good software testing practices with 2+ years of experience as a Software Tester, QA Analyst, Software QA Engineer, or a Validation Manager.
- Good communication skills, with the ability to coordinate with multiple teams and stakeholders on timelines and roadmaps.
- Ability to understand the business/product domains and apply it to positive and negative testing.
- Ability to apply risk-based principles to areas of testing investment.
Nice to Haves
- Familiarity with the healthcare industry and Computer Systems Validation.
- Familiarity with agile software development processes.
- Familiarity with working with a QA/Risk/Compliance organization.
- Familiarity with Jira or a similar project management tool.
We offer competitive compensation because we want to hire the best people and reward them for their contributions to our mission. We pay all employees competitively relative to the New York City market, regardless of their location. In compliance with NYC's pay transparency law and in pursuit of pay equity and fairness, we publish salary ranges for all open roles at TrialSpark. The target salary range for this role is $108,000 - $140,000.
On top of base salary, we also offer equity, generous perks, location flexibility, and comprehensive benefits - learn more about them and our compensation philosophy here .
If this range doesn't match your expectations, please still apply because we may have something else for you.
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.