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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical project management, including budget management, risk assessment, and cross-functional team leadership. Proficient in developing project management plans and ensuring adherence to clinical trial processes and regulatory guidelines.
Highest-signal resume keywords
Clinical Project ManagementBudget ManagementCross-Functional Team LeadershipClinical Trial ProcessesRisk Assessment
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 PlansBudget ForecastingProtocol DevelopmentData-Driven Decision MakingClinical Trial ProcessesICH-GCP GuidelinesFederal RegulationsStudy Start-UpStudy Close-OutVendor Management
Soft Skills
Strong Communication SkillsDiplomatic Negotiation SkillsProblem-Solving SkillsTeam CoordinationMentoring
Industry Keywords
Life SciencesPublic HealthCRO EnvironmentNeurologyAnalgesiaRespiratoryImmunologyDermatologyClient LiaisonInspection Readiness
About the role
Key responsibilities & impact- Lead clinical projects, including cross-functional project teams and vendors, or work alongside a global Project Lead on larger, complex, or global studies
- Establish and maintain project timelines
- Organize and lead project team meetings and manage follow-up
- Develop and maintain project management plans
- Review functional area plans and project documents for consistency and alignment with scope of work
- Establish and manage project vendor and site budgets
- Forecast budgets and activities and track out-of-scope activities
- Ensure budget adherence by internal and external team members
- Oversee vendor contracts, site budgets, and contract amendments
- Manage the Investigator Grant Payment process
- Negotiate client requests involving scope changes or business expansion
- Manage cross-functional project resources and assign tasks to staff and vendors
- Identify additional resource needs and provide performance feedback
- Serve as the primary project and client liaison
- Build and maintain positive client and stakeholder relationships
- Identify, evaluate, and manage project risks and study trends
- Coordinate inspection readiness efforts and participate in audits and inspections
- Review operational metrics and address project risks and issues
- Provide status updates to leadership and clients, including slides and presentations for oversight meetings
- Build relationships with global, cross-functional project team members
- Train and mentor Project Management employees, including Project Managers, APMs, and Project Associates
- Support Contracts and Proposals and Business Development teams with RFIs, RFPs, and bid defenses
Requirements
What you’ll need- Bachelor’s Degree, preferably in life sciences or public health
- At least 3 years working in clinical project management, ideally within a CRO environment
- Ideally, experience in neurology, analgesia, respiratory, immunology or dermatology
- Knowledge of clinical trial processes and client expectations
- Ability to lead components of clinical projects, including study start-up and close-out
- Ability to establish and manage project budgets and develop project management plans
- Understanding of protocol development and/or review
- Familiarity with the drug development process, ICH-GCP guidelines, and federal regulations
- Ability to proactively identify project issues and lead resolution within the team
- Problem-solving skills, judgment, and ability to anticipate necessary action
- Ability to make data-driven decisions and resolve issues proactively
- Strong written, verbal, presentation, and communication skills
- Diplomatic negotiation skills
- Ability to lead, coordinate, and motivate teams
- Ability to delegate and prioritize work for self and team members
Benefits
Comp & perks- Medical insurance
- Vision insurance
- Dental insurance
- HSA
- FSA
- EAP
- Life and disability insurance
- 401(k)
- Paid time off
- Holidays
- Parental leave
- Bereavement leave
- Work-life balance flexibility
- Career growth opportunities
- Financial rewards
