Senior Operational Advisor (DQRS) (Remote)

Location: Hybrid

Medidata follows a hybrid office policy in which employees who are hired for an in-person position are expected to work on site a certain number of days per week in accordance with Company policy.

About our Company:

Medidata is powering smarter treatments and healthier people through digital solutions to support clinical trials. Celebrating 25 years of ground-breaking technological innovation across more than thirty six thousand trials and 11 million patients, Medidata offers industry-leading expertise, analytics-powered insights, and one of the largest clinical trial data sets in the industry. More than 1 million users trust Medidata's seamless, end-to-end platform to improve patient experiences, accelerate clinical breakthroughs, and bring therapies to market faster. Discover more at www.medidata.com.

About the Team:

The Professional Services Senior Operational Advisor – Data Quality and Risk Surveillance (DQRS) is a strategic leadership role responsible for guiding clients through the transformation of their clinical data and risk management operating models.

As a senior subject matter expert, you will partner with executive stakeholders to design and implement scalable, future-ready approaches to Risk-Based Quality Management (RBQM) and Risk-Based Data Management (RBDM), leveraging Medidata’s Unified Platform, including Clinical Data Studio.

This role extends beyond implementation to focus on operational transformation, change management, and long-term adoption, enabling clients to move from fragmented, reactive processes to integrated, data-driven decision-making at scale.

Responsibilities:

Strategic Advisory & Transformation Leadership

• Serve as a trusted advisor to senior and executive stakeholders, guiding the evolution of clinical data and RBQM operating models
• Lead strategic workshops and transformation engagements, including current-state assessments, future-state design, and roadmap development
• Advise on the integration of Data Management and RBQM into a unified Risk-Based Data Management (RBDM) framework
• Drive alignment with industry standards (e.g., ICH E6 R3) and emerging best practices

Implementation & Adoption Excellence

• Provide senior-level oversight and advisory support across implementation and enablement activities
• Ensure successful adoption of Medidata Clinical Cloud solutions, with a focus on Clinical Data Studio
• Guide clients in establishing scalable workflows for:
  • signal detection and analysis
  • site-level risk profiling
  • audit trail review
  • action tracking and escalation
• Support some clients in transitioning from CRO-dependent models to internalized, scalable operating structures

Operational Expertise & Value Realization

• Deliver deep expertise across Clinical Operations, Data Management, and RBQM
• Enable clients to move from data monitoring to active risk management through integrated analytics and workflows
• Support development of site-level intelligence, signal-to-action frameworks, and effort-based monitoring strategies
• Provide advanced reporting and analytical guidance to drive insight generation and decision-making

Cross-Functional Collaboration & Growth

• Partner closely with Sales and Account teams to support expansion and long-term client success
• Contribute to proposal development, bid defenses, and executive presentations
• Collaborate with Product, Engineering, and other SMEs to represent client needs and influence product direction

Thought Leadership & Capability Development

• Develop and deliver operational best practices, frameworks, and reusable assets
• Lead and contribute to accreditation programs and internal enablement initiatives
• Mentor and coach junior team members and peers
• Act as a thought leader internally and externally (e.g., conferences, client forums)

Internal Responsibilities (Approx. 15%)

• Maintain deep expertise in DQRS products and industry trends
• Contribute to product feedback, enhancements, and roadmap discussions
• Support development of training materials and global education programs
• Ensure alignment with Medidata implementation standards and quality processes
• Participate in product forums and cross-functional initiatives

Qualifications:

• Strategic thinking and transformation leadership with the ability to define and drive future-state operating models
• Strong change management and stakeholder alignment skills across complex organizations
• Deep understanding of clinical trial processes, RBQM, and data management workflows
• Ability to challenge legacy processes and drive adoption of innovative approaches
• Excellent communication and executive presentation skills
• Proven ability to operate independently while influencing cross-functional teams
• Strong problem-solving and decision-making capabilities
• Willingness to travel up to 30%
• Typically 8+ years of experience in Clinical Operations, Data Management, RBQM, or related roles within Sponsor, CRO, or equivalent organizations
• Demonstrated experience in clinical trial risk identification and management
• Proven track record in:
• leading transformation or change initiatives
• advising clients or stakeholders at a senior/executive level
• driving adoption of clinical technology solutions
• Experience supporting or leading complex implementations of clinical systems
• Involvement in business development, bid defenses, or client presentations preferred
• Bachelor's degree required or equivalent experience
• Clients successfully transition to scalable, integrated RBQM and data management models
• Increased client adoption and expansion of Medidata Clinical Cloud solutions
• Measurable improvements in efficiency, visibility, and decision-making speed
• Recognition as a trusted strategic partner by client stakeholders

As with all roles, Medidata sets ranges based on a number of factors including function, level, candidate expertise and experience, and geographic location. 

• The salary range for positions that will be physically based in the NYC Metro Area is  $135,000.00 to $180,000.00
• The salary range for positions that will be physically based in the San Francisco, CA area  is $141,750.00 to 189,000.00
• The salary range for positions that will be physically based in the Boston Metro Area is $132,750.00 to 177,000.00
• The salary range for positions that will be physically based in Texas or Ohio is $118,500.00 to 158,000.00
• The salary range for positions that will be physically based in all other locations within the United States is $120,750.00 to $161,000.00

Base pay is one part of the Total Rewards that Medidata provides to compensate and recognize employees for their work. Most sales positions are eligible for a commission on the terms of applicable plan documents, and many of Medidata's non-sales positions are eligible for annual bonuses. Medidata believes that benefits should connect you to the support you need when it matters most and provides best-in-class benefits, including medical, dental, life and disability insurance; 401(k) matching; flexible paid time off; and 10 paid holidays per year.

Note: Please be on the lookout for job scams. Medidata recruiters will never ask applicants for monetary compensation, credit card, or banking details.

Equal Employment Opportunity:

In order to provide equal employment and advancement opportunities to all individuals, employment decisions at Medidata are based on merit, qualifications and abilities. Medidata is committed to a policy of non-discrimination and equal opportunity for all employees and qualified applicants without regard to race, color, religion, gender, sex (including pregnancy, childbirth or medical or common conditions related to pregnancy or childbirth), sexual orientation, gender identity, gender expression, marital status, familial status, national origin, ancestry, age, disability, veteran status, military service, application for military service, genetic information, receipt of free medical care, or any other characteristic protected under applicable law. Medidata will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Applications will be accepted on an ongoing basis until the position is filled.

#LI-TC1

#LI-Remote 

Inclusion Statement

As a game-changer in sustainable technology and innovation, Medidata, a Dassault Systèmes company, is striving to build more inclusive teams across the globe. We believe that our people are our number one asset and we want all employees to feel empowered to bring their whole selves to work every day. It is our goal that our people feel a sense of pride and a passion for belonging. As a company leading change, it’s our responsibility to foster opportunities for all people to participate in a harmonized Workforce of the Future.