FREE ACCESS
5,000–10,000 jobs/day
See all jobs on Scoutfield
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical trial management, particularly in study start-up processes, regulatory submissions, and site activation strategies. Proven ability to lead cross-functional teams and manage multiple projects while ensuring compliance with EUCTR and regional regulatory requirements.
Highest-signal resume keywords
Clinical Trial ManagementEUCTR ExperienceProject ManagementSite ActivationRegulatory Document Review
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 ExperienceStudy Start-Up RoleICF ReviewRegulatory SubmissionProject ManagementRisk MitigationQuality AssuranceMetrics ReportingDocument Quality CheckOperational Readiness
Soft Skills
Strong Communication SkillsOrganizational SkillsLeadership SkillsProactive MindsetProblem-Solving Ability
Tools & Technologies
CTMSETMFVeevaMicrosoft ProjectClinical Trial Management Trackers
Industry Keywords
Contract Research OrganizationRegulatory AuthoritiesSite Activation StrategyPatient-Facing MaterialsCross-Functional Teams
About the role
Key responsibilities & impact- Lead day-to-day management of multiple projects or a multi-study program for site activation
- Drive regional site selection processes to ensure timely and efficient activation
- Oversee site activation according to timelines and quality standards across a region
- Communicate site activation strategy to country teams and monitor progress
- Serve as a subject matter expert in EUCTR and ensure timely collection of Part 2 documents
- Ensure ECs and regulatory authorities are paid within appropriate timeframes
- Coordinate SSU specialists across regions and keep sites on track with the critical-path activation plan
- Escalate regulatory and vendor setup issues identified by SSU specialists
- Monitor project status, identify risks, and provide metrics to the Study Start-up Oversight Lead
- Develop mitigations for risks to study timelines
- Facilitate knowledge transfers across countries within regions
- Collaborate with Regional/Oversight Leads to resolve issues and maintain the agreed plan
- Oversee EC submission strategy and required patient-facing materials, including ICFs and questionnaires
- Manage country and site ICF timelines; review and approve country ICFs
- Quality-check EC submission packages and essential document packages
- Ensure operational readiness for site activation, including site binders, ancillary supplies, lab kits, training, and system access
- Coordinate stakeholder information flow and timely site activation form sign-off
- Ensure consistency and application of processes within studies
- Initiate and execute study-related progress reports
- Provide oversight and management of amendment implementation
Requirements
What you’ll need- Bachelor’s Degree in life sciences or equivalent (e.g., pharmacy, nursing)
- Clinical trial experience, with solid experience in a study start-up role and at a regional level
- Experience in a study start-up group, specifically ICF review, regulatory document review, and submission experience, managing startup for the European region
- Previous experience in a Contract Research Organization (CRO) is essential
- Strong EUCTR experience, previously involved in submissions
- Proven experience in project management and site activation
- Strong communication, organizational, and leadership skills
- Proactive mindset with the ability to identify bottlenecks and propose solutions
- Ability to manage multiple projects, coordinate cross-functional teams, and work in a matrix environment
- Proven ability to handle a high volume of tasks of varying complexity and effectively utilize escalation pathways
- Excellent communication skills (listening, oral, written) in English
- Comfortable using CTMS, eTMF, Veeva, and Microsoft Project
- Familiarity with regional regulatory processes and requirements
- Experience in leading cross-functional teams effectively
- Advanced proficiency in clinical trial management trackers and tools
Benefits
Comp & perks- Learning, growth, and opportunities to expand skills
- Inclusive and belonging-focused culture
- Diverse and innovative team environment