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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical research project management, ensuring compliance with ICH GCP and local regulations while leading cross-functional teams to deliver high-quality clinical trials. Proficient in monitoring clinical activities, managing data-related issues, and driving successful site activations.
Highest-signal resume keywords
Clinical Research Project ManagementICH GCP ComplianceOncology ExperienceCross-Functional Team LeadershipDrug Development Process Knowledge
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 MonitoringData ManagementProject PlanningRisk MitigationSite ActivationRegulatory ComplianceQuality AssuranceStudy Activity MonitoringContingency PlanningClinical Operations Processes
Soft Skills
Effective Decision-MakingStrong Interpersonal SkillsCollaborationAdaptabilityCommunication
Tools & Technologies
IT Systems
Industry Keywords
Clinical StudiesOnco-HematologyTrial Data CollectionInspection ReadinessLife Science Degree
About the role
Key responsibilities & impact- Plan and lead day-to-day activities for monitoring complex clinical studies
- Communicate project objectives, expectations, and status updates to clinical teams
- Take overall responsibility for country study commitments and timely, high-quality data delivery
- Provide project oversight and leadership for clinical deliverables
- Lead and manage clinical teams and relevant local and global staff
- Drive successful activation of trial sites
- Monitor clinical activity quality and address quality issues
- Review and approve site visit reports and ensure tracking, follow-up, and resolution of site issues
- Identify data-related issues and risks and develop contingency and mitigation plans
- Create and maintain project-specific plans, documents, and tools
- Support CRAs with site monitoring activities and provide solutions to site issues
- Oversee regulatory and in-house clinical staff to ensure required updates, reports, renewals, and end-of-study notifications comply with protocols, local regulations, ICH GCP, and governing procedures
- Coordinate training, processes, systems-related activities, and ad-hoc activities
Requirements
What you’ll need- Bachelor degree in related discipline, preferably in life science
- Five or more years of experience in clinical research, including a minimum of 2 years' project management experience, or an equivalent combination of education and experience sufficient to successfully perform the key responsibilities of the job
- Good knowledge of international guidelines ICH GCP and relevant local regulations
- Proven ability to lead and motivate cross functional teams to deliver clinical trials according to or ahead of time plan, budget and required quality
- Previous work experience in Oncology or Onco-hematology is required
- Good knowledge of the Drug Development Process
- Excellent knowledge of spoken and written English language
- Good ability to learn and adapt to work with IT systems
- Effective decision-making ability
- Experience monitoring study activities for compliance and inspection readiness
- Strong interpersonal skills for collaborating with internal teams, stakeholders, and external vendors
- Deep understanding of clinical operations processes, including trial data collection and management
Benefits
Comp & perks- Full-time, home-based setting
- Opportunity to manage clinical research projects in different therapeutic areas
- Opportunity to cooperate closely with a key client
