Head of Clinical Operations

| Greater NYC Area
Apply now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

About TrialSpark

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 the Head of Clinical Operations at TrialSpark, you’ll be responsible for leading and managing four key groups within TrialSpark: Clinical Project Management, Patient Operations, Vendor Management and Data Management.  This role will be a primary stakeholder in roadmap development across all Clinical Operations functions. Your day-to-day activities will include the implementation and execution of the overall clinical studies strategy, ensuring consistency, quality and compliance with global clinical standards and regulations.  You will work with team members to create the operational strategies for the TrialSpark studies portfolio, as well as promote innovation and process excellence within and across all TrialSpark functions. In addition to running the day-to-day, you will be charged with driving innovation and efficiency in the clinical trial process.

TrialSpark is looking for a First Principles thinker who can develop and execute on a solid clinical operations strategy.  We are only looking for candidates who can help us create a world where clinical trials are thought of differently; in line with our mission to bring new treatments to patients faster by reimagining the clinical trials process.

Key Responsibilities will include:

Leadership: 

  • Provide strategic direction and leadership for collaboration of key TrialSpark teams, including Clinical Project Management, Patient Operations, Data Management and the TrialSpark Study Operations teams to ensure cross-functional efficiency to support all TrialSpark clients.
  • Develop and execute on strategies for scaling TrialSpark operations, creating efficiencies and delivering high quality clinical trials.
  • Assess and implement innovative clinical trial and data management approaches, focusing on quality and efficiency.
  • Represent TrialSpark externally to Sponsors, Partners and Regulatory Authorities.
  • Oversee end-to-end tracking of clinical trial delivery and collaboration with other functions to identify and mitigate issues as they arise to ensure timely and on-budget trial execution.
  • Provide direction and mentorship to staff including setting goals that are aligned with both corporate and project goals.

Project Management:

  • Oversee technical expertise for the development of clinical trial documentation and trial conduct, including oversight of Key Performance Indicators, Key Risk Indicators and budgetary indicators both within and across programs.
  • Oversee the preparation and management of clinical trial budgets and timelines, as well as appropriate tracking mechanisms and tools.
  • Develop clinical operational standards, such as SOPs, forms, templates and tools as necessary to ensure timely, efficient and high quality clinical trial deliverables.
  • Establish and maintain inspection readiness across all programs.

Business Development:

  • Determine clinical operations requirements for all sponsor (Pharma and Biotech) request for proposals, including labor, non-labor and third party costs.
  • Represent TrialSpark’s clinical operations team in sponsor-facing Bid Defense meetings.
  • Accountable for ensuring the clinical operations resources assigned to a trial are the most appropriate for the sponsor’s requirements.

About you

  • A demonstrated ability to plan and lead teams in executing complex global clinical trials.
  • Deep experience with all aspects of study management, including feasibility, study planning and budgeting, study resourcing, vendor management, risk management, stakeholder management, and more.
  • Thorough knowledge and understanding of clinical research concepts, practices, and regulations.
  • 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.
  • Competency with data analysis: should have intermediate+ ability with Excel, and fluency with managing to metrics and key performance indicators.

Skills & Competency

  • Expertise in drug development, operations and strategic planning, as well as clinical operations and clinical project management.
  • Very experienced and knowledgeable in the Code of Federal Regulations (CFR), International Council for Harmonization Good Clinical Practices (ICH-GCP).
  • Knowledge of other GxP areas such as Good Manufacturing Practices (GMP) and Good Documentation Practices (GCP).
  • Ability to work on and solve complex problems.
  • Proven ability to foster team productivity, cohesiveness and collaboration.
  • Excellent communication skills and experience in a dynamic and growing organization.

Qualifications

  • BS or BA required, preferably in life sciences or a related field; advanced degree preferred.
  • Minimum of 15 years experience in the pharmaceutical and/or biotechnology industry.
  • Minimum of 10 years of clinical operations experience, preferably including a strong background in clinical project management.
  • Experience working with CROs (in a sponsor capacity) or at a CRO is required.

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.

Read Full Job Description
Apply now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.

Technology we use

  • Engineering
    • JavascriptLanguages
    • PythonLanguages
    • ReactLibraries
    • ReduxLibraries
    • FlaskFrameworks
    • PostgreSQLDatabases

Location

Our office is located in the Flatiron District of NYC, near Madison Square Park. The area is lively and has great food and transportation options!

An Insider's view of TrialSpark

What are some social events your company does?

We believe in healthy living! We organize regular team exercise classes as a company!

Frank Wu

Product Manager

How do you empower your team to be more creative?

We believe in presenting problems, not solutions, to the team. Our job is to align the team on company goals and issues, and allow the team to work creatively to solve them. We believe team autonomy fosters creativity and a healthier culture.

Linhao Zhang

CTO

What are TrialSpark Perks + Benefits

TrialSpark Benefits Overview

Trialspark is nothing without its employees, so they are well taken care of! We offer comprehensive benefits that span from insurance to 401ks, with added perks like a pet-friendly office. Come meet our office dog, Rosie!

Health Insurance & Wellness Benefits
Flexible Spending Account (FSA)
Dental Benefits
Vision Benefits
Health Insurance Benefits
Life Insurance
Retirement & Stock Options Benefits
401(K)
Company Equity
Child Care & Parental Leave Benefits
Generous Parental Leave
Flexible Work Schedule
Vacation & Time Off Benefits
Unlimited Vacation Policy
Paid Holidays
Paid Sick Days
Perks & Discounts
Casual Dress
Commuter Benefits
We have a monthly transportation subsidy!
Company Outings
Yearly retreat and holiday party, regular team events and outings!
Game Room
Super Smash Club every Friday!
Stocked Kitchen
Happy Hours
Pet Friendly
Come meet our office dog, Rosie!
Relocation Assistance
Fitness Subsidies
Professional Development Benefits
Job Training & Conferences
More Jobs at TrialSpark10 open jobs
All Jobs
Dev + Engineer
Marketing
Operations
Project Mgmt
Sales
Operations
new
New York
Developer
new
New York
Marketing
new
Remote
Sales
new
New York
Operations
new
New York
Operations
new
New York
Sales
new
New York
Project Mgmt
new
Remote
Project Mgmt
new
New York
Apply now
By clicking continue you agree to Built In’s Privacy Policy and Terms of Use.
Save jobView TrialSpark's full profileSee more TrialSpark jobs