Director, Study Management

Background

Today, 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 $100M+. And the problem is only getting worse.

At TrialSpark, we don’t believe it has to be this way. Through technology and a new operational model, we’re reimagining how clinical trials are run, with the mission of bringing new treatments to patients faster. 

We do this by partnering with physicians to enable them to run clinical trials within their existing practices. By providing the technology platform, equipment, and staffing, TrialSpark alleviates the operational burden of clinical research, enabling physicians to focus on what they do best -- patient care.  And by bringing clinical research to physician practices, TrialSpark is enabling access for the 98% of patients who are never exposed to clinical trial opportunities.

Job Description

As the Director, Study Management, you will be responsible for the clinical execution of all studies across TrialSpark’s trial site network. You will build and manage the team responsible for overseeing the day-to-day clinical operations of TrialSpark’s portfolio of studies, ensuring they have the training, tools, and processes needed deliver high quality results.

You will also partner closely with our QA, Product, and other Operations teams to develop the training, processes, products, and enablement infrastructure to support our large, diverse team of study coordinators in delivering consistent and high quality study services.

This is a key operational leadership role for TrialSpark. You will be responsible for the core of what TrialSpark delivers – efficient and high quality clinical trial operations. We’re looking for someone with the experience to set the vision for what this looks like, and the operational chops to build the teams, systems, and processes to make it happen.

Responsibilities:

  • Oversee the team responsible for the clinical execution of Phase II - IV research studies, where TrialSpark is either providing a subset of sites, or managing the entire end-to-end study.
  • Develop and execute on strategies for scaling our operations, creating efficiencies, and delivering higher quality.
  • Own KPIs for clinical aspects of all studies, including metrics related to study startup timelines, data entry timeliness, and data quality.
  • Work closely with our Product, Engineering, and Data teams to develop new capabilities to increase efficiency and quality; you will be a primary stakeholder in roadmap development across our technical functions.
  • Partner cross-functionally to build the system for hiring, training, and enabling TrialSpark’s study coordinator team.
  • Oversee regulatory compliance across all studies.
  • Represent TrialSpark externally to sponsors, partners, and regulatory authorities.
  • Constantly re-assess how we are executing clinical research, challenging assumptions and questioning the status quo.

An ideal candidate:

  • You have 10+ years of experience in clinical operations, including 5+ years leading large clinical operations teams at a Biopharma company or CRO.
  • You possess a deep understanding of site-level quality and GCP, including best practices for drug management, regulatory, source data, clinical supplies, etc.
  • You have successfully navigated or conducted sponsor and regulatory audits in the past, and can define “what good looks like” for constant audit readiness.
  • You are highly process-oriented, with an ability to break complex systems apart and design efficient and scalable workflows.
  • You are comfortable operating in a fast-paced environment with a high degree of ambiguity.
  • You are proactive, strategic, implementation-focused, and ready to roll up your sleeves and make an impact right away.
  • You excel in partnering cross-functionally. You are known for being someone that people across the company love to work with.
  • You are low ego, collaborative, and a fast-learner.

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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