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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in trial management, including site feasibility, recruitment strategies, and budget forecasting. Proficient in ICH-GCP compliance and effective communication with stakeholders to ensure trial success.
Highest-signal resume keywords
Trial End-To-End ManagementHemOnc ExperienceICH-GCP KnowledgeBudget ForecastingSite Recruitment Strategy
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Trial ManagementSite FeasibilityData Quality ManagementRisk ManagementBudget ManagementCorrective And Preventive ActionsInformed Consent PreparationAdverse Event ReportingDatabase LocksTrial Progress Analysis
Soft Skills
Communication SkillsTeam CoordinationTraining FacilitationStakeholder EngagementProblem-Solving
Tools & Technologies
CTMSETMF/IFTrial Management SystemsVendor Management SystemsData Analysis Software
Industry Keywords
Clinical TrialsHealth SciencesRegulatory ComplianceSite ManagementEarly Phase Trials
About the role
Key responsibilities & impact- Serve as a site-aligned end-to-end partner throughout trial lifecycles
- Act as the primary point of communication for assigned trial sites, investigators, and site staff
- Participate in site feasibility, site qualification visits, follow-up, and final site selection
- Lead and coordinate local team activities to meet recruitment targets, data quality, timelines, and study budget
- Develop local trial procedures and tools, recruitment plans, contingency plans, risk management, and budget forecasts
- Maintain investigator engagement and communicate trial status and issues to stakeholders
- Maintain and update trial management systems and analyze trial progress
- Initiate corrective and preventive actions when trials deviate from plans
- Contribute to site-level recruitment strategy and contingency planning
- Manage country-level vendors, invoices, vendor selection, and local study supplies
- Conduct local trial team meetings and facilitate study-monitoring training
- Prepare and manage country- and site-specific informed consent forms
- Ensure adverse events, serious adverse events, and product quality complaints are reported within required timelines
- Maintain inspection readiness through complete and accurate trial data and essential documents in CTMS and eTMF/IF
- Ensure site data quality and timely query resolution
- Support CAPA implementation for audits, inspections, and quality visits
- Ensure accurate finance reporting and proactive management of country/local trial budgets
- Organize and ensure IEC/HA approvals with the local Start Up team
- Provide training or input into process initiatives when applicable
- Complete timely and accurate time reporting
- Manage and start up complex Early Phase trials with internal matrix clinical teams and sites, as applicable
Requirements
What you’ll need- BA/BS degree
- Degree in a health or science related field
- 3 - 5+ years of trial end to end management experience
- Start-up & Database Locks/Cleaning experience preferred
- HemOnc experience required
- Strong working knowledge of ICH-GCP, company standard operating procedures, local laws and regulations, assigned protocols and associated protocol specific procedures
- Strong IT skills in appropriate software and company systems
- Proficient in speaking and writing the country language and English
- Good written and oral communication skills as appropriate
- Legally authorized to work in the United States
- Must not require, now or in the future, sponsorship for employment visa status
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