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 design, execution, and compliance with GCP and ICH guidelines, while effectively managing cross-functional teams and mentoring junior staff. Possesses strong analytical, problem-solving, and communication skills to navigate complex clinical environments and drive successful outcomes.
Highest-signal resume keywords
Clinical Trial ExperienceProject ManagementGCP ComplianceScientific WritingCross-Functional Collaboration
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 DevelopmentClinical Study DesignData ReportingRegulatory ManagementMedical WritingPatient RecruitmentResearch DesignsTrial DesignMultiple Therapeutic AreasClinical Trials Monitoring
Soft Skills
Problem-SolvingEffective CommunicationMentoringCreative ThinkingLeadership
Industry Keywords
Good Clinical Practice (GCP)ICH GuidelinesClinical DevelopmentClinical ReportingPhase 1 Clinical TrialsSafety ReportingRegulatory NDA SubmissionStudy OperationsProcedure ManualsScientific Research
About the role
Key responsibilities & impact- Provide operational and scientific leadership for the design, planning, and execution of early-phase clinical trials and programs
- Collaborate with the Clinical Director and cross-functional teams
- Oversee strategic direction and execution of clinical trials and programs
- Manage cross-functional team performance to achieve trial objectives
- Ensure execution excellence and compliance with GCP, ICH, and regulatory requirements
- Assess clinical safety and manage compound risks
- Provide real-time oversight of ongoing trials and identify or mitigate participant, study design, data, and conduct issues
- Review and interpret clinical trial data
- Participate in on-site monitoring at clinical sites, including site training and supervision of complex endpoint/biomarker collection
- Represent Early-Stage Clinical Development on early and product development teams
- Develop departmental job aids and SOPs and participate in or lead cross-functional teams developing global clinical development procedures
- Identify and communicate organizational best practices
- Promote adoption of new procedures and coach, mentor, and develop junior team members
- Represent the company at professional events and present clinical initiatives, projects, and trial results
- Author clinical protocols, investigator brochures, clinical study reports, health authority update reports, regulatory responses, and audit/inspection documents
- Author and coordinate WMA/CTD subsections
- Assist Clinical Directors with scientific leadership, investigator initiatives, publications, meeting presentations, and due diligence
- Develop study operational documents, including site monitoring plans, study operations/laboratory manuals, risk language, and informed consents
- Lead teams through study planning and execution, issue escalation and mitigation, senior management presentations, governance meetings, and advisory meeting preparation
- Manage trial and program projects, team meetings, collaborative workspaces, and document management
- Provide risk assessments and contingency planning under accelerated timelines
Requirements
What you’ll need- Degree in Life Sciences
- Bachelor’s degree and ≥11 years related experience, OR Master’s degree and ≥8 years related experience, OR PhD or doctorate degree and ≥3 years related experience
- At least 6 years clinical trial experience in a clinical scientist or clinical operations role
- Experience developing, implementing, and managing clinical programs and trials to ensure efficient, timely execution against milestones
- Ability to think creatively, explore novel ways of working, and navigate ambiguity
- Ability to solve complex problems and use independent judgment relating to regulations, guidelines, and investigator interactions
- Ability to develop working scientific knowledge of different therapeutic areas
- Excellence in complex project management and managing multiple projects/priorities
- Ability to work effectively across boundaries and apply cultural differences to communication and collaboration
- Excellence in scientific, medical/safety writing, and reporting
- Ability to make data-driven decisions, identify and escalate issues, and plan mitigations
- Ability to partner effectively with external teams
- Effective written and oral communication, problem-solving, and analytical skills
- Working knowledge of GCP, ICH guidelines, and regulatory requirements
- Ability to mentor junior staff
- Leadership or participation in a cross-functional initiative addressing a business gap or process improvement
- Must act with courage and candor
- Preferred: at least 6 years Phase 1 clinical trial experience
- Preferred: global Phase 1 patient trials, safety reporting, and regulatory NDA/WMA submission experience
- Clinical Development, Clinical Reporting, Clinical Research, Clinical Study Design, Clinical Trial Development, Clinical Trials Monitoring, Clinical Trials Operations, Data Reporting, Good Clinical Practice (GCP), Medical Writing, Multiple Therapeutic Areas, Patient Recruitment, Procedure Manuals, Regulatory Management, Research Designs, Scientific Research, Scientific Writing, Study Design, Trial Design
- No visa sponsorship
- US and Puerto Rico residents only
Benefits
Comp & perks- Annual bonus and long-term incentive, if applicable
- Medical, dental, vision healthcare and other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
- Hybrid work arrangement