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Senior Director, Data Integrity QA

TrialSpark

TrialSpark

Sales & Business Development, Quality Assurance
New York, NY, USA · Remote
Posted on Tuesday, April 4, 2023

About TrialSpark

On a mission to bring new treatments to patients faster and more efficiently

Founded in 2016, TrialSpark is a tech-driven Pharma company differentiated by radically more efficient drug development. TrialSpark has built a technology platform that optimizes all aspects of clinical drug development, enabling more efficient trial design, faster trial completion, and higher quality trial data.

The company acquires clinical-stage drugs from pharmaceutical and biotech companies and develops them faster, unlocking greater value per program and accelerating access to new treatments for patients. TrialSpark's current therapeutic areas of focus include rheumatology, dermatology, CNS, and cardiometabolic diseases.

About the Position

TrialSpark is seeking a data integrity expert to join our Quality Assurance Team. You will set the strategy and oversee our approach to data integrity, data governance and computer systems validation, partnering with cross-functional teams across the business. You will work closely with the Engineering, Product, TechOps, and Biometrics teams as a thought partner, and to ensure system compliance, advise on our data processes, lead deviation management, and provide audit support.

Responsibilities

  • Provide oversight and set the strategy for TrialSpark’s approach to data integrity, data governance and computer systems validation (CSV).
  • Understand and guide how data are collected across various stages of the pharmaceutical lifecycle; ensuring controls and processes are in place for internal and external products.
  • Partner closely with Engineering, Biometrics, Product, and TechOps to continually evolve our strategy and approach, and ensure compliance with regulations.
  • Oversee the planning, implementation, and administration of data governance and data integrity related initiatives; ensuring international readiness.
  • Conduct internal and external audits; serve as a data integrity representative for audits and regulatory inspections.
  • Provide oversight and guidance for deviation management and CAPAs as related to data incidents across TrialSpark.

About You

  • You have a degree in Computer Science, Software Engineering, Informatics, Biomedical, or other related technical field.
  • You have at least 10-15 years of relevant experience in computer systems validation, software validation and change management in the pharmaceutical industry and quality organization.
  • You have a proven track record of setting the data governance and integrity strategy, embedding it, and driving adoption across an organization.
  • You have a deep understanding of GXP and SDLC regulations, including 21 CFR Part 11, computer systems validation requirements (including 2023 guidances) and good documentation practices.
  • You have demonstrated strong project management skills and enjoy working collaboratively with software development teams.
  • You are a strong written and verbal communicator.

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 $227,000 - $290,000.

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.