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Senior Project Manager
Evolution Research Group. Lead the execution of clinical research projects or programs and ensure compliance with applicable regulations, guidelines, and corporate policies .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in leading clinical research projects, ensuring compliance with FDA regulations, GCP, and ICH Guidelines. Proficient in project management, budget development, and team supervision while maintaining operational integrity and effective communication with stakeholders.
Highest-signal resume keywords
Clinical Project ManagementFDA Regulations KnowledgeGCP and ICH Guidelines ComplianceBudget Development and ManagementVendor Management Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Clinical Research ExecutionProject Budget ManagementProtocol Writing and ReviewData ManagementRisk AnalysisStudy Plan DevelopmentInformed Consent Form CreationCase Report Form InstructionsRegulatory Authority Inspection ParticipationProject Management Tools Implementation
Soft Skills
Organizing and Coordinating SkillsTeaching and Facilitation SkillsJudgment and Problem-SolvingMulti-tasking AbilityTeam Leadership
Industry Keywords
CRO ExperienceClinical Fellowship ProgramInvestigational SitePharmaceutical CompanyClinical Study Reports
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead the execution of clinical research projects or programs and ensure compliance with applicable regulations, guidelines, and corporate policies
- Lead projects through the full cycle, including scope, budget, and resource assessment
- Act as primary liaison between the company and sponsors for project launch, conduct, and closeout
- Communicate with sponsors, cross-functional teams, project vendors, and site staff
- Communicate project progress, generate periodic updates, and prepare formal presentations
- Coordinate with clinical, marketing, and operations management to identify study goals and scope
- Ensure operational and regulatory integrity of assigned studies
- Participate in FDA or other regulatory authority inspections as needed
- Develop study plans, informed consent forms, case report form instructions, site selection materials, investigator updates, and other project documents
- Identify project risks and analyze scope, cost, resource, and timeline impacts
- Develop, manage, and track project budgets
- Implement project management tools, techniques, and processes for informed decision-making
- Participate in clinical data review and analysis
- Train, mentor, and coach junior staff and provide feedback
- Ensure tasks meet client expectations and comply with contracts, trial protocols, and SOPs
- Support continuous improvement of project delivery practices
- Maintain current knowledge of FDA regulations and GCP and ICH Guidelines
- Supervise assigned team members and provide higher-level guidance on project management tools and processes
- Attend off-site meetings and conferences as needed
Requirements
What you’ll need- Bachelor degree or equivalent education/degree in life science/healthcare is required
- 8 years of working within clinical project management at a local medical organization, investigational site, pharmaceutical company, CRO, or clinical fellowship program
- CRO experience is highly desirable
- Experience qualifying and managing external vendors
- Experience leading project operational teams through the start-up, study conduct, data management, and report writing of clinical studies
- Experience writing, reviewing, and editing protocols and clinical study reports
- Working knowledge of the FDA submission process
- Knowledge of FDA regulations and GCP and ICH Guidelines for clinical research
- Extensive organizing and coordinating skills
- Teaching and facilitation skills
- Ability to assess training needs and objectives
- Extensive experience overseeing and coordinating the work of others
- Ability to handle multiple tasks simultaneously and manage multiple deadlines
- Ability to exercise judgment and determine appropriate action for problems of varying complexity
- Strong desire to take ownership of multiple projects
Benefits
Comp & perks- Attend off-site meetings and conferences, as needed
- Educational opportunities and professional development through reading professional publications, maintaining professional networks, and participating in professional organizations