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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in project management for clinical trials, including the development of project plans, risk mitigation strategies, and compliance with GCP/ICH guidelines. Proficient in coordinating study activities, maintaining documentation, and supporting audit readiness.
Highest-signal resume keywords
Project ManagementClinical Trial Process KnowledgeGCP/ICH GuidelinesStudy Documentation ManagementCTMS Setup and Updates
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project Management PlansRisk Mitigation PlansTrial Management ToolsStudy ID RequestsETMFRegulatory DocumentsProtocol DesignsStudy ProceduresBudget ManagementFeasibility Assessments
Soft Skills
Organizational SkillsCommunication SkillsTeam CollaborationAttention to DetailProblem-Solving Skills
Tools & Technologies
SharePointCTMSSAS EnvironmentProject LogsRisk Registers
Industry Keywords
Clinical ResearchHealthcareRegulatory Authority GuidelinesEarly Clinical PharmacologyStudy Objectives
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Coordinate and complete project tasks supporting Project Management for low-complexity studies
- Initiate study-specific documents, including Project Management Plans, Communication Plans, and Risk Mitigation Plans
- Develop trial management tools and monitor study activity, project setup, timelines, and trackers
- Schedule and organize study-related meetings; distribute agendas and maintain and distribute minutes, project logs, risk registers, and contact lists
- Transfer study documents to the Trial Master File in accordance with SOPs, policies, systems, and client requirements
- Develop, distribute, and finalize study-specific plans and training matrices with senior Project Coordinators or Project Managers
- Maintain standardized filing structures and proactively maintain study-related documents
- Complete project setup activities, including study ID requests, SAS environment setup, eTMF, and distribution lists
- Assist with CTMS setup and updates
- Participate in client visits and support eTMF audit readiness and quality reviews
- Post study documents to internal SharePoint or client websites after required training
- Support business improvement initiatives
- Serve as sponsor and site contact during maintenance phases when requested and approved
- Assist with payments, sponsor/internal training, project tools, regulatory binders, feasibility, site startup, contracts, budgets, regulatory documents, and EC/IRB submissions
- Lead or assist with external site calls and act as a point of contact for external sites
- Maintain project timelines, finance/screening/vendor trackers, and support work-scope changes related to sponsor contracts
- Perform other assigned duties
Requirements
What you’ll need- All candidates must reside in the United States
- University/college degree, preferably in a healthcare/scientific field; specific clinical research experience may be substituted for education
- Relevant and equivalent experience may be considered in lieu of educational requirements
- English required for speaking, writing, and reading
- Knowledge of the clinical trial process; early clinical pharmacology experience preferred
- Minimum 1–2 years of experience in a research environment
- Knowledge of protocol designs, study objectives, study procedures, and project-related timelines
- Knowledge of GCP/ICH Guidelines and applicable Regulatory Authority Guidelines
- Regular and consistent attendance
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf
- Ability to perform the stated physical requirements, including stationary work, repetitive hand movements, bending/twisting, and lifting 15–20 lbs
- Varied hours may be required
