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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Lifecycle Safety management, project financial oversight, and regulatory compliance within clinical research. Proven ability to lead cross-functional teams, manage customer relationships, and drive business growth through effective communication and strategic planning.
Highest-signal resume keywords
Lifecycle Safety ManagementProject ManagementRegulatory ComplianceFinancial AnalysisCustomer Relationship Management
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 ExperienceProject Financial ManagementBudget CreationRevenue RecognitionProposal DevelopmentRisk ManagementOperational SupportMetrics ReportingAudit SupportLifecycle Safety Service Lines
Soft Skills
Leadership SkillsEffective CommunicationConflict ManagementCollaboration SkillsRelationship-Building
Certifications & Qualifications
Bachelor's Degree in Health Science
Industry Keywords
Contract Research OrganizationPharmaceuticalClinical Research Regulatory RequirementsProject PlanningCustomer-Focused
About the role
Key responsibilities & impact- Manage customer interface and communication for assigned projects/programs and serve as the primary Lifecycle Safety point of contact
- Manage customer deliverables, including project planning, timelines, deliverables, scope, quality and project financial management
- Act as an account owner over programs or customer portfolios and report program/portfolio-level metrics
- Craft and defend proposed solutions for new standalone Safety business opportunities
- Formulate operational budgetary assumptions and steer budget creation, customization of text and data
- Serve as Safety Subject Matter Expert and point of contact for Governance, Executives and Integrated Partners
- Lead customer-facing collateral, operational support, presentations and meetings
- Provide leadership from scoping and proposal generation through bid defense, work transition, service delivery and the commercial lifecycle
- Manage project finances, including financial systems, revenue recognition, invoicing, budget review, financial analysis and change orders
- Monitor revenue, direct costs, timesheet costs and contribution margin
- Work with sales and proposals on tailored opportunity responses and drive business growth
- Manage project start-up, identify risks and implement mitigation measures
- Lead internal and external stakeholder meetings and provide project status updates
- Lead virtual Lifecycle Safety project teams and coordinate with operational teams
- Facilitate sales activities, sales presentations, bid defenses and proposal development
- Develop customer partnerships, support contract renewal and identify new business opportunities
- Develop innovative cross-functional solutions based on current and future customer needs
- Contribute to client and internal audits and inspections and support corrective action plans
- Collaborate with Lifecycle Safety Management to resolve problems and customer needs
Requirements
What you’ll need- Bachelor's Degree Health science or other directly related field
- 4 to 6 years' clinical research experience in a Contract Research Organization or Pharmaceutical company, combining 4 years of Lifecycle Safety experience and 2 years of project management experience
- Strong knowledge of applicable global, regional and local clinical research regulatory requirements
- Working knowledge of Lifecycle Safety service lines; willingness to increase knowledge across Lifecycle Safety service lines and develop new skills
- Excellent team management and leadership skills, including conflict management
- Strong project management, planning and organizational skills
- Effective verbal and written communication skills, including ability to network and lead teleconferences
- Effective collaborative, organizational and delegation skills
- Ability to establish and maintain effective working relationships with coworkers, managers and customers
- Ability to deliver on multiple projects and manage competing priorities
- Ability to manage ambiguity
- Effective business focus, marketing and sales skills
- Proven strong presentation, report writing and customer focus skills
- Ability to achieve results through communication, facilitation and negotiations in a matrix service delivery environment with shared accountabilities
- Independent judgment, negotiating, decision-making and problem-solving skills
- Effective business acumen and financial analytical skills, tactical planning and budgeting
- Customer-focused with effective relationship-building skills
- Effective motivating, influencing and conflict-resolution skills