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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in Clinical Trial Management, ensuring compliance with Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines while effectively managing project finances and stakeholder communication.
Highest-signal resume keywords
Clinical Trial ManagementGood Clinical Practice (GCP)International Conference on Harmonization (ICH)Project Management PracticesClinical Research Industry 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 ConductProject Finances ManagementRisk Mitigation PlanningQuality Standards IdentificationRecruitment Strategy DevelopmentProtocol KnowledgeStakeholder ManagementRegulatory Compliance MonitoringMilestone Achievement SupportPerformance Feedback Provision
Soft Skills
Effective CommunicationTeam CollaborationResolution ManagementLeadershipFeedback Delivery
Industry Keywords
Clinical ResearchDrug DevelopmentDevice TechnologyRegulatory RequirementsClinical Quality Issues
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Ensure clinical delivery of assigned projects in compliance with regulatory requirements (International Conference on Harmonization (ICH)-Good Clinical Practice (GCP), protocol)
- Accountable for meeting projects’ recruitment targets and ensuring appropriate recruitment strategies are in place
- Contribute to the development of the project risk mitigation plan. Manage clinical risks through the project lifecycle
- Ensure clinical quality delivery by identifying quality standards/requirements, planning how compliance will be measured, monitoring and overseeing management of clinical quality issues
- Manage clinical aspects of Project Finances including Estimate at Completion (EAC)
- Work as the primary CTM alongside other CTMs to deliver large, global trials
- Identify clinical stakeholder landscape for the project and manage both internal and external stakeholders through effective communication and resolution management
- Collaborate with the clinical team to support milestone achievements
- Conduct regular team meetings and communicate appropriately to achieve objectives
- Support professional development by providing feedback to clinical team line managers on performance relative to project tasks
- May contribute to the development of the clinical delivery strategy for business proposals
Requirements
What you’ll need- Bachelor's Degree in health care or other scientific discipline required
- Ideally at least 5 years experience in clinical trial management or equivalent combination of education, training and experience
- Requires consolidated knowledge of Project management practices and terminology
- Requires good knowledge of applicable clinical research regulatory requirements i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Requires broad protocol knowledge and therapeutic knowledge.
- Requires good understanding of Clinical Research industry (drug/device/technology/etc.) and the relevant environments in which it operates
- Requires understanding of project finances
- Knowledge of clinical trials - Knowledge of clinical trial conduct, and skill in applying applicable clinical research regulatory requirements i.e. International Conference on Harmonization (ICH) and Good Clinical Practice (GCP) and relevant local laws, regulations and guidelines, towards clinical trial conduct.
Benefits
Comp & perks- health insurance
- retirement plans
- paid time off
- flexible work arrangements
- professional development
