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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing global clinical research projects, ensuring adherence to ICH Guidelines and GCP standards while effectively leading project teams and maintaining client satisfaction. Proficient in project planning, risk management, and performance tracking to deliver projects within scope, schedule, and budget.
Highest-signal resume keywords
Global Project Management ExperienceClinical Research ExperienceKnowledge of ICH Guidelines and GCPPMP CertificationAdvanced Computer Skills
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 ManagementClinical Trial ExecutionRegulatory Data CompilationFinancial Tracking SystemsProject PlanningRisk ManagementPerformance Indicators DevelopmentResource ManagementChange Control ProcessesOncology or Ophthalmology Experience
Soft Skills
Excellent Communication SkillsOrganizational SkillsTeam LeadershipConflict ResolutionMentoring
Tools & Technologies
Microsoft WordMicrosoft ExcelMicrosoft ProjectMicrosoft AccessMicrosoft PowerPoint
Certifications & Qualifications
PMP CertificationAdvanced Degree (Preferred)
Industry Keywords
Pharmaceutical CompanyCROBiotech ExperienceClinical Development ProgramsMatrix Environment
Tech Stack
Tools & technologiesGoogle Cloud PlatformPMP
About the role
Key responsibilities & impact- Oversee and manage domestic, regional, and/or global clinical research projects, at times under the direction of a Project Director
- Develop and manage project teams, communications, risk, scope, schedule, cost, quality, and stakeholders
- Proactively mitigate variance from plan and ensure client expectations are met
- Apply working knowledge of drug development and clinical trial execution
- Compile and drive project documentation, ensuring accuracy and quality of regulatory data
- Serve as key client contact for assigned projects
- Establish working relationships with client project teams to support client satisfaction and operational excellence
- Lead core project teams and facilitate extended project teams, ensuring effective cross-functional teamwork among internal and external stakeholders
- Serve as escalation point for project issues
- Proactively identify and resolve conflicts
- Understand project delivery strategy, costing assumptions, and project budgets
- Deliver projects to agreed scope, schedule, cost, and quality targets
- Manage internal and external change control processes
- Lead quality control and risk assurance activities
- Create, manage, and revise project plans; monitor progress against plans
- Ensure assigned staff follow professional standards and SOPs and provide performance feedback
- Develop and maintain project performance indicators and client-specified KPIs
- Define and manage project resource needs and succession plans
- Prepare and deliver new-business presentations with relevant departments
- Train and mentor PM Academy PCs
- Potentially perform line management and talent development responsibilities
- Align resources with current and forecasted work
- Support onboarding, development, retention, talent-bench strengthening, and succession
- Assess project-management competencies and create developmental plans
- Provide line management and technical support to project leaders, including training, development, and performance reviews
- Perform other duties assigned by management
Requirements
What you’ll need- 2-5+ years of global project management experience stated in the opening summary
- Candidates must be based in the United States
- University/college degree (life science preferred) or certification in a related allied health profession from an appropriately accredited institution
- Fortrea may consider relevant and equivalent experience in lieu of educational requirements
- Minimum of seven (7) years of relevant clinical research experience in a pharmaceutical company/CRO
- At least two (2) years of full project management responsibility
- Working knowledge of ICH Guidelines and GCP, including international regulatory requirements for clinical development programs
- Advanced computer skills, including Microsoft Word, Excel, Project, Access, and PowerPoint
- Experience managing projects in a matrix and virtual environment
- Excellent communication, planning, and organizational skills
- Demonstrated ability to lead by example and encourage team members to seek solutions independently
- Demonstrated ability to handle multiple competing priorities and utilize resources effectively
- Demonstrated ability to inspire effective teamwork and motivate staff within a matrix system
- Financial awareness and ability to actively utilize financial tracking systems
- Good knowledge of project management processes
- Ability to work independently and mentor junior project team members
- Ability to negotiate and liaise with clients professionally
- Ability to present to staff at all levels
- Oncology or Ophthalmology experience
- Preferred: Master’s or other advanced degree
- Preferred: PMP certification
- Preferred: Biotech experience
- Ability to sit for extended periods and operate a vehicle safely
- Repetitive hand movement of both hands with ability to make fast, simple, repeated movements of fingers, hands, and wrists
- Occasional crouching and stooping, with frequent bending and twisting of upper body and neck
- Ability to access and use a variety of computer software
- Light to moderate lifting and carrying, up to 15–20 lbs
- Regular and consistent attendance
- Varied hours may be required
Benefits
Comp & perks- Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
- 401(K)
- Paid time off (PTO) – Flex Plan
- Employee recognition awards
- Multiple ERG’s (employee resource groups)
- Full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits
