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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in managing clinical trials, including oversight of clinical teams, development of clinical trial documents, and ensuring compliance with Good Clinical Practices. Proficient in mentoring staff, managing study budgets, and coordinating with cross-functional teams to achieve study objectives.
Highest-signal resume keywords
Clinical Trial ManagementMentoring and TrainingRegulatory ComplianceProject ManagementClinical Risk 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
Clinical Monitoring PlansStudy KPIsQuality ControlData AnalysisSite Activation DocumentationSOP DevelopmentInvestigational Product ManagementProtocol Deviation TrackingPatient Recruitment StrategiesMonitoring Evaluation Visits
Soft Skills
Effective CommunicationCollaborationLeadershipProblem-SolvingTeam Management
Industry Keywords
Good Clinical PracticesClinical ResearchTherapeutic Area ExpertiseSite AuditsStudy Non-Compliance
About the role
Key responsibilities & impact- Manage assigned clinical teams, including CRAs
- Develop, review, and revise clinical trial documents, including Clinical Monitoring Plans
- Support project managers with study KPIs, timelines, budgets, invoicing, and staff time approval
- Contribute to clinical risk management and Critical to Quality Factors and Quality Tolerance Limits
- Recommend investigators and sites and review and approve PSV reports
- Oversee site initiations, supply management, site activation documentation, CRA assignments, and site visit schedules
- Organize internal project team meetings and provide study status and protocol deviation updates
- Support setup and maintenance of trial master files and oversee ongoing and final quality control
- Review CRA site visit reports and ensure timely, high-quality completion
- Manage investigational product and study supplies
- Review data listings and query reports, identify trends, and implement mitigation or retraining actions
- Oversee protocol deviation and study non-compliance documentation, tracking, escalation, and corrective/preventive actions
- Act as site contact when CRAs are unavailable and escalate unresolved issues to project management
- Oversee clinical staff tasks, including CRA travel approvals
- Manage trial close-out activities
- Communicate and collaborate with sponsors, investigators, partners, and cross-functional teams
- Support patient recruitment and retention plans
- Coordinate preparation for site audits and inspections and oversee corrective and preventive action plans
- Mentor and train new staff and conduct Monitoring Evaluation Visits
- Oversee contracting or invoicing of local clinical vendors
- Develop and revise SOPs in accordance with Good Clinical Practices and regulatory requirements
- Participate in bid defense meetings and company process improvement initiatives
- Perform monitoring activities as needed based on project needs
Requirements
What you’ll need- Degree or RN degree in a life science or other related field, or equivalent education and experience
- Minimum of 6 years of clinical research experience in multiple studies and countries
- Experience managing the clinical part of studies in more than one region or equivalent study complexities
- Ability to mentor and train other CTMs and CRAs in a positive and effective manner
- In-depth knowledge of clinical trials and the critical elements for success in clinical trials
- Diverse therapeutic area expertise and skills
Benefits
Comp & perks- Collaborative, international team environment
- Career growth opportunities
- Flexible work environment
- Work-life balance
- Passionate and collaborative team of experts
- Opportunity to help bring safe and effective pharmaceutical treatments to patients worldwide