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 initiation and regulatory compliance, with a strong understanding of ICH-GCP guidelines and local regulatory requirements. Proven ability to manage regulatory submissions and collaborate effectively with cross-functional teams to enhance study start-up efficiency.
Highest-signal resume keywords
Clinical Trial InitiationRegulatory ComplianceStudy Start-Up ActivitiesEthics Submissions ManagementProject 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
Regulatory Document PreparationClinical Trial ApplicationsEthics Committee SubmissionsRegulatory Agency CommunicationsRegulatory Submissions Management
Soft Skills
Excellent Organizational SkillsExcellent Communication SkillsInterpersonal SkillsCollaboration Skills
Industry Keywords
ICH-GCPClinical ResearchRegulatory AffairsNorth America RegionStudy Start-Up Best Practices
About the role
Key responsibilities & impact- Lead the initiation of clinical trials, ensuring compliance with regulatory requirements
- Contribute to site start-up and activation activities
- Prepare and submit regulatory documents, including clinical trial applications, ethics committee submissions, and regulatory agency communications
- Coordinate with internal and external stakeholders to obtain approvals and authorizations for study initiation
- Manage and maintain records of regulatory submissions, approvals, and correspondence
- Provide guidance and support to study teams on regulatory requirements and study start-up best practices
- Participate in process improvement initiatives to streamline study start-up processes and enhance efficiency
Requirements
What you’ll need- Bachelor's degree in life sciences or a related field
- Minimum of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start-up activities
- Strong understanding of regulatory requirements and guidelines for clinical trials, including ICH-GCP and local regulatory requirements
- Demonstrated experience in ethics submissions and management of the ethical review process for clinical studies conducted at study sites in the United States
- This role supports the North America region (U.S. and Canada)
- Excellent organizational and project management skills, with the ability to prioritize and manage multiple tasks simultaneously
- Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams
- Legal right to work in the country where the role is based
Benefits
Comp & perks- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways