Senior Clinical Domain Expert

About the role

You will own the clinical strategy and domain expertise that shapes how our AI driven tools solve real world trial challenges, ensuring that automation respects the complexity of sponsor needs. You will translate intricate Trial Master File regulations and CRA workflows into clear requirements that guide our engineering and product teams. Acting as a trusted advisor, you will challenge assumptions and refine solutions so they align with both compliance realities and operational efficiency. You will partner closely with early adopter sites and sponsors to test, learn, and iterate on features before broad release. Your work will directly influence how Veeva Falcon supports the life sciences industry in accelerating therapy delivery to patients. You will help define what success looks like for clinical operations in the age of intelligent automation. You will ensure that every output from our tools maintains the highest standards of data integrity and regulatory appropriateness. Through your leadership, you will bridge the gap between cutting edge technology and the day to day realities of running clinical trials.

Key facts

What you'll do

Conduct in depth analysis of current Trial Master File processes and CRA activities to uncover automation opportunities for Veeva Falcon.

Architect and define the functional design for clinical operations features, ensuring they support scalable and compliant trial execution.

Serve as the primary domain authority, challenging proposed AI outputs and validating them against practical sponsor and site workflows.

Collaborate with implementation specialists and quality teams to build clear standard operating procedures and training materials.

Partner with early adopter organizations to gather feedback, refine use cases, and drive successful adoption of new automation capabilities.

Evaluate data models and content structures to ensure they accommodate the full spectrum of TMF sponsor requirements and global regulations.

Lead the creation of detailed business requirements, user stories, and acceptance criteria that translate clinical needs into technical solutions.

Support the development of a scalable go to market narrative that highlights the operational and compliance benefits of Veeva Falcon automation.

Champion the voice of the customer throughout the product lifecycle, from initial concept through deployment and optimization.

Identify and mitigate potential compliance risks by mapping features to regulatory expectations and industry best practices.

Act as a hands on problem solver, investigating complex trial scenarios and proposing enhancements to improve automation accuracy.

Enable customers to extract maximum value from Veeva Falcon by demonstrating how intelligent features can streamline TMF and CRA responsibilities.

Work cross functionally with engineering, product, sales, and services teams to ensure alignment on priorities and delivery timelines.

Act as a thought leader, contributing to discussions on the future of clinical operations and the role of automation in life sciences.

Requirements

You possess a Bachelor's degree or higher in a life sciences discipline, ensuring you understand the scientific context of the work.

You hold current certification as a Clinical Research Associate (CRA) or equivalent professional credential in clinical operations.

You have a minimum of ten years of hands on experience in clinical trial operations, with at least five years specifically as a CRA.

You bring at least five years of direct experience working with Trial Master File organization, content, and regulatory expectations.

You are thoroughly familiar with current Good Clinical Practice and the associated regulations that govern clinical research.

You understand the roles, responsibilities, and challenges of sponsors, contract research organizations, and investigative sites.

You have a documented history of adapting to changing regulations and implementing process improvements in clinical operations.

You demonstrate strong analytical skills, enabling you to assess complex workflows and identify opportunities for automation.

Nice to have

Experience with AI tools and platforms, and a clear point of view on how they can augment clinical operations work.

Familiarity with Veeva products and the life sciences cloud ecosystem, including prior implementations or adoptions.

Background in developing standard operating procedures or training materials for clinical operations teams.

Exposure to global trial operations and the nuances of managing TMF across different regulatory jurisdictions.

Practical notes

Full time role based in Massachusetts

Boston.

Work is exempt.

At Veeva, we offer a comprehensive benefits package, including medical, dental, and vision coverage, that may vary by location.

All employment is subject to the Veeva background check program and drug testing policies.

We are an equal opportunity employer and celebrate diversity.

We are not able to sponsor visas for this role.

Candidates must be authorized to work in the United States without sponsorship.

This role is not eligible for relocation assistance.

The work location for this role is fixed and not eligible for flexible work arrangements outside of Veeva's Work Anywhere policy.

This role is not eligible for commission or variable pay.

This role does not require travel.