Senior Clinical Research Project, Trial Manager

Saratoga Ascend

. Oversee multi-site or complex clinical trials from start-up through close-out .

Posted 11/5/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

Use this summary to align your resume positioning with the role.

Demonstrates extensive experience in overseeing multi-site clinical trials, managing NIH- or FDA-regulated studies, and ensuring compliance with Good Clinical Practice and regulatory standards. Proven leadership in coordinating multidisciplinary teams and effective stakeholder communication.

Highest-signal resume keywords

Clinical Research ExperienceMulti-Site Clinical Trials ManagementRegulatory Compliance KnowledgeLeadership in Multidisciplinary TeamsQuality Assurance Oversight

ATS Keywords

Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills

Clinical Trial ManagementData ManagementRegulatory Functions CoordinationTask-Order ManagementBudget ManagementRisk ManagementCorrective Action TrackingQuality AssuranceGene Therapy StudiesRare Disease Studies

Soft Skills

Stakeholder CommunicationTeam Leadership

Tools & Technologies

Good Clinical Practice (ICH E6)21 CFR Parts 11, 50, 54, 56, 312, 81245 CFR Part 46HIPAA

Certifications & Qualifications

Bachelor's Degree in Life SciencesMaster's DegreePMP CertificationCCRP CertificationACRP-CP CertificationCurrent Human Subjects Protections Training

Industry Keywords

Clinical TrialsNIH-Regulated StudiesFDA-Regulated StudiesMultidisciplinary Team EnvironmentGovernment Reporting

Tech Stack

Tools & technologies

PMP

About the role

Key responsibilities & impact

Oversee multi-site or complex clinical trials from start-up through close-out
Manage task-order or contract deliverables, schedules, budgets and risks
Coordinate clinical operations, monitoring, data management, regulatory and quality functions
Provide quality assurance oversight and track corrective actions
Support staffing and transition planning
Lead multidisciplinary teams and coordinate with Government clinical investigators, regulatory staff and program officials
Provide stakeholder communication and Government reporting

Requirements

What you’ll need

Bachelor's degree in life sciences, nursing, public health or a related field required
Minimum of 8 years of clinical research experience
At least 5 years managing NIH- or FDA-regulated studies and leading multidisciplinary teams
Demonstrated oversight of multi-site or complex clinical trials from start-up through close-out
Experience managing task-order or contract deliverables, schedules, budgets and risks
Proven ability to coordinate clinical operations, monitoring, data management, regulatory and quality functions
Experience with quality assurance oversight, corrective action tracking, and staffing and transition planning
Strong leadership, stakeholder communication and Government reporting skills
Working knowledge of Good Clinical Practice (ICH E6), 21 CFR Parts 11, 50, 54, 56, 312 and 812 (as applicable), 45 CFR Part 46, and HIPAA
Current human subjects protections and GCP training (e.g., CITI or equivalent)
Experience working in a multidisciplinary team environment alongside Government clinical investigators, regulatory staff and program officials
Master's degree or PMP/CCRP/ACRP-CP certification preferred
Experience with gene therapy or rare disease studies is advantageous

Benefits

Comp & perks

Competitive rate
Benefit options