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Senior Clinical Project Manager
ClinChoice. Lead and coordinate complex clinical projects across pharmaceutical, biotechnology, medical device, and consumer health clients .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in managing complex clinical projects across various sectors, ensuring compliance with GCP/ICH Guidelines and regulatory requirements while maintaining project timelines and budgets. Proficient in coordinating teams and maintaining strong Sponsor relationships to deliver successful clinical trial outcomes.
Highest-signal resume keywords
Clinical Research Project ManagementGCP/ICH Guidelines KnowledgeSponsor Relationship ManagementMicrosoft Office ProficiencyCRO Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
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Hard Skills
Clinical Trial OperationsProject ManagementData Documentation ManagementElectronic Data CaptureStudy Protocol DevelopmentCase Report Form ManagementRegulatory Document PreparationBudget ManagementTimeline ManagementCo-Monitoring Visits
Soft Skills
Team CoordinationCommunicationProblem-SolvingTraining and MentoringPerformance Monitoring
Industry Keywords
PharmaceuticalBiotechnologyMedical DeviceConsumer HealthClinical Research AssociateClinical MonitorRare Disease StudiesRespiratory StudiesGLP-1 StudiesRegulatory Compliance
Tech Stack
Tools & technologiesGoogle Cloud Platform
About the role
Key responsibilities & impact- Lead and coordinate complex clinical projects across pharmaceutical, biotechnology, medical device, and consumer health clients
- Manage project-specific Sponsor services, including central lab exams, drug shipments, and document shipments
- Coordinate Sponsors, Investigators, and project team members
- Manage study data documentation, including CRFs, patient diaries, questionnaires, queries, study supplies, regulatory documents, and correspondence
- Ensure project timelines and budgets are maintained
- Monitor workload and performance of the project team
- Plan and monitor team tasks
- Coordinate Clinical Research Associate and Clinical Monitor activities
- Collaborate on local authority approvals, biometrics, safety, regulatory, and archiving activities
- Assist the Medical Monitor with protocols, Case Report Forms, and final Clinical Study Reports
- Deliver project-specific training and organize Monitor, Investigator, and project update meetings
- Provide project updates to Sponsors, Senior Project Managers, and Project Directors/Leaders
- Escalate issues to the Project Director/Leader
- Perform co-monitoring visits as necessary
- Tutor Project Coordinators and Project Manager I
- Maintain Sponsor relationships
- Prepare SOPs for clinical research activities and enforce Company procedures
Requirements
What you’ll need- Bachelor's Degree or equivalent University Degree in scientific and/or medical or paramedical disciplines; an equivalency consisting of appropriate education, training and/or directly related experience may be considered
- At least 8 years of clinical research experience in Project Management
- Previous experience managing respiratory, rare disease, general medicines and/or GLP-1 studies
- Previous CRO experience
- Excellent knowledge of clinical trial operations, GCP/ICH Guidelines and applicable regulatory requirements
- Fluent in English
- Proficiency in Microsoft Office, including Word, Excel, and Outlook
- Previous CRA experience highly desirable
- Prior experience in electronic data capture preferred
Benefits
Comp & perks- Professional development
- Strong work-life balance
- Collaborative, quality-driven “one-team” culture
- Continuous training and close management
- Equal opportunity and inclusive workplace