Clinical Systems Implementation Lead

MSD

. Manage validation, implementation, and adoption of clinical-trial applications .

Posted 10/19/2026full-timeUnited StatesSenior💰 $173,200 - $272,600 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in managing clinical trial applications, ensuring compliance with regulatory standards, and leading cross-functional teams. Proficient in clinical systems implementation, project management, and data governance principles.

Highest-signal resume keywords

Clinical Systems ImplementationProject ManagementData GovernancePeople LeadershipClinical Trial Processes

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial Management Systems (CTMS)Electronic Trial Master File (eTMF)Electronic Data Capture (EDC)Data Analysis ToolsSystem ValidationImplementationQuality ManagementRegulatory ComplianceBusiness Process Re-EngineeringMetrics Identification

Soft Skills

Strong Verbal CommunicationWritten CommunicationConflict ResolutionAdaptabilityCustomer Service Orientation

Tools & Technologies

MS Office ToolsClinical PortalsQuality Control Management ToolsRisk Management ToolsChange Management Tools

Industry Keywords

Drug DevelopmentClinical TrialsGood Clinical Practice (GCP)International Council for Harmonisation (ICH)Data Stewardship

Tech Stack

Tools & technologies

Google Cloud PlatformSDLC

About the role

Key responsibilities & impact

Manage validation, implementation, and adoption of clinical-trial applications
Lead and manage team members supporting clinical systems activities
Partner with Global Clinical Development, Research & Development Division-IT, vendors, functional SMEs, and end users to assess needs and implement solutions
Ensure compliance with company policies, agency regulations, SDLC requirements, data stewardship, and data governance principles
Support systems audits and inspections, follow up on findings, and manage CAPAs
Engage systems quality leads early in upgrades and re-platforming to ensure SDLC compliance
Train Clinical Systems Implementation team members on SDLC requirements
Contribute to BEO leadership activities, intern projects, internship recruiting, and quarterly business reviews
Monitor technology trends, profile vendors, and map capabilities to business requirements
Create business cases and advance solutions from proof of concept through pilot and scaled implementation
Collect user feedback and collaborate with user experience experts to optimize user experience
Develop technology and innovation roadmaps with business and IT sponsors
Define and manage KPIs for technology solution outcomes
Lead workstreams or sub-streams for larger technology initiatives
Create change and communication plans to support adoption and share best practices
Own assigned systems, including migrations and decommissioning
Allocate team resources and justify additional headcount
Recruit, interview, onboard, and manage team performance and development
Conduct 1:1s, performance reviews, feedback sessions, risk management, and escalations
Ensure team training compliance and adequate helpdesk support, case tracking, and trending
Oversee functional requirements, system validation, implementation, operational activities, data flows, governance, process impact assessments, inspection readiness, BCPs, SOPs, releases, account reviews, and compliant application adoption

Requirements

What you’ll need

BS degree with 10+ years' experience; OR MS/MBA/JD degree with 8 years' experience; OR PhD degree with 5 years' experience in Science, Clinical Research, Computer Science, or similar fields
Two to five years of people management experience required
Broad understanding of drug development, including safety, clinical trials, trial design, data management, trial operations, regulatory, privacy, ICH, and GCP
Ability to quickly gain thorough understanding and become subject matter expert in new business areas
Strong verbal and written communication skills
Ability to interact with all levels of management and influence outcomes without authority
Project and resource management experience
Deep knowledge of clinical trial processes and quality management and control tools
Experience with CTMS, eTMF, EDC systems, clinical portals, basic reporting, and MS Office tools
Understanding of metrics and ability to identify trends
Experience in system validation, implementation, systems analysis, and systems maintenance/support
Fluency with cross-functional interdependencies, roles, and enabling tools/technologies
Ability to identify critical inputs and outputs driving business processes and workflow/dataflow dependencies
Exposure to a global environment with multicultural and organizational operating models
Management and leadership skills, analytical ability, good judgment, multitasking, conflict resolution, and discretion
Customer service orientation and ability to work effectively with clients, third-party vendors, quality, and IT management/staff
Experience training user communities
Required skills include Adaptability, Benchmarking, Business Process Re-Engineering, Clinical Systems Implementation, Cross-Functional Teamwork, Data Analysis Tools, Decision Making, Good Manufacturing Practices, Innovation, IT Implementation, People Leadership, Professional Integrity, Quality Control Management, Risk Management, and Strategic Planning
No visa sponsorship
US and Puerto Rico residents only

Benefits

Comp & perks

Annual bonus and long-term incentive, if applicable
Medical, dental, vision healthcare and other insurance benefits for employee and family
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Hybrid flexible work arrangements
No relocation