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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials, ensuring compliance with Good Clinical Practice (GCP) and applicable laws, while effectively coordinating cross-functional teams and managing budgets. Proficient in preparing essential trial documents and maintaining Trial Master Files to support successful study execution.
Highest-signal resume keywords
Good Clinical Practice (GCP) CertificationClinical Project Management ExperienceBudget and Contract ManagementVendor and Clinical Site ManagementCross-Functional Team Leadership
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 Trial ManagementStudy Protocol DevelopmentData Quality AssuranceRisk Assessment and MitigationBiological Sample Logistics ManagementTrial Master File MaintenanceInvestigational Product LogisticsFinancial Management Systems InputStakeholder CommunicationMulti-Site Study Coordination
Soft Skills
NegotiationExpectation ManagementTeam CoachingCross-Functional CommunicationContinuous Improvement Mindset
Certifications & Qualifications
Good Clinical Practice (GCP) Certification
Industry Keywords
Clinical TrialsFood IndustryPharmaceutical IndustryCRO IndustryICH GuidelinesStakeholder AgreementOperational Phase ManagementStudy Budget DevelopmentClinical Site SelectionTrial Subject Protection
About the role
Key responsibilities & impact- Manage the operational phase of clinical trials to ensure timely delivery of quality data in compliance with internal SOPs, applicable laws, and ICH Good Clinical Practice
- Contribute to study protocol outlines and budget development
- Assess clinical site and staff suitability and secure stakeholder agreement
- Lead and coordinate activities to operationalize study protocols independently
- Deliver clinical trial statistical reports according to agreed baseline timelines
- Conduct and document operational activities to ensure collected-data quality
- Track and manage study contracts and provide input into financial management systems
- Deliver studies within agreed budgets and report budgets to relevant SBU or business project managers
- Prepare, review, quality-control, and collate essential study documents in the Trial Master File
- Ensure adherence to ICH GCP guidelines and applicable laws for inspections and audits
- Ensure trial subject protection
- Contribute to continuous improvement of working processes
Requirements
What you’ll need- Good Clinical Practice (GCP) Certified
- Minimum of 4-5 years clinical project management experience in Food/Pharma/CRO industry
- Experience leading and coordinating cross-functional operational teams and communicating with internal and external trial stakeholders
- Experience preparing and/or reviewing essential trial documents, maintaining Trial Master Files, and managing EC approval processes
- Budget and contract management experience
- Vendor and clinical site selection, oversight, and management experience
- Experience coordinating investigational product preparation, logistics, and supply management throughout trials
- Experience managing biological sample logistics
- Experience working with clinical sites to execute protocols
- Experience managing and coaching CRAs and other clinical trial personnel
- Experience managing multi-site, international clinical studies
- Experience with risk assessment, mitigation plan implementation, and continuous review and adjustment of plans
- Ability to convince, negotiate with, and manage expectations of key clinical trial stakeholders, including business/NRC project managers, internal medical development teams, and external KOLs and their teams
Benefits
Comp & perks- Opportunity to make a local and global impact
- Professional and personal growth opportunities
- Encouragement and enablement to grow as professionals and people
