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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 leading cross-functional teams through complex clinical trials while ensuring compliance with regulatory standards. Proficient in financial forecasting, project budgeting, and managing relationships with stakeholders in a fast-paced environment.
Highest-signal resume keywords
Clinical Project ManagementCross-Functional Team LeadershipClinical Trial ConceptsPMP CertificationFinancial Acumen
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 Study ExperienceProject ManagementTrial Master File ManagementMicrosoft Office SuiteTechnical Writing
Soft Skills
Exceptional CommunicationInterpersonal SkillsProblem-SolvingNegotiation SkillsOrganizational Skills
Tools & Technologies
MS ProjectExcel (Pivot Tables, VLOOKUP)
Certifications & Qualifications
PMP Certification
Industry Keywords
Clinical TrialsICH-GCPRegulatory RequirementsPharmaceuticalBiotechnology
Tech Stack
Tools & technologiesPMP
About the role
Key responsibilities & impact- Prepare and/or review study-related and essential study start-up documents for assigned clinical trials
- Serve as Clinical Project Manager and ensure Study Management teams meet study timelines and deliverables
- Oversee and lead study-specific study management resources
- Develop and manage groups of studies for a business unit or large development program
- Mentor other Clinical Project Managers
- Provide critical thinking and leadership during clinical study execution issues
- Write protocols, clinical study reports, and other clinical study deliverables
- Lead or contribute to continuous improvement initiatives
- Manage relationships with sites, principal investigators, CROs, and other study-related vendors
- Develop and maintain integrated project plans and facilitate project meetings
- Define, track, and report schedules, interdependencies, achievements, critical paths, and deliverables
- Adapt work package deliverables based on study scale and complexity
- Create resource and budget forecasts and timelines
- Direct cross-functional team members and vendors on technical, protocol-specific, and operational study aspects
- Identify and manage project risks and issues, including mitigations and contingencies
- Maintain high-quality standards and compliance requirements
- Perform other assigned duties
Requirements
What you’ll need- Bachelor's degree, preferably in the life sciences, clinical, or other relevant technical areas
- Minimum of 5 years of clinical study experience in pharmaceutical, medical device, IVD, biotechnology, or CRO environments
- Proven ability to lead cross-functional clinical teams through complex, global, multicenter studies from initiation through closeout
- Minimum of 5 years of project management experience, preferably using MS Project
- Strong knowledge of clinical trial concepts, international clinical research guidelines, and regulatory requirements
- Hands-on experience managing Trial Master Files (TMF) in compliance with ICH-GCP and regulatory standards
- Ability to influence cross-functional teams without formal authority
- Financial acumen, including project budgeting, financial forecasting, and strategic recommendations
- Strong project management, client relationship, and vendor relationship management skills
- Ability to work independently with multi-level teams and manage multiple projects in a fast-paced, changing environment
- Exceptional written and verbal communication, interpersonal, negotiation, and relationship-management abilities
- Expert-level knowledge of clinical operations procedures
- Exceptional problem-solving, organizational, analytical, and critical-thinking abilities
- Strong leadership skills
- Proficiency in Microsoft Office Suite, including expert-level Excel skills with Pivot Tables and VLOOKUP
- Proven ability to work effectively in a remote environment
- Ability to travel approximately 20% and reside near a major airport
- Advanced degree desirable, including MS, MBA, PhD, MPH, PharmD, or MD
- PMP certification highly desirable
- Technical and/or medical writing experience desired
Benefits
Comp & perks- Comprehensive Total Rewards program
- Reward and recognition opportunities
- Competitive compensation and benefits programs
- Flexible work-life balance considerations
- Remote or field-based workplace arrangements as indicated
- Learning, growth, and development opportunities
- COVID-19 vaccination accommodation consideration pursuant to applicable law
