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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in project management within a CRO environment, including regulatory compliance, budget management, and team leadership. Proficient in developing communication and training plans while ensuring audit-ready documentation and effective stakeholder engagement.
Highest-signal resume keywords
Project Management ExperienceRegulatory Compliance KnowledgeTeam Leadership and SupervisionBudget Management SkillsExcellent Communication Skills
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Project ManagementRegulatory Document PreparationBudget TrackingProtocol DevelopmentClinical Management PlansRisk AssessmentProcess ImprovementProject Metrics InterpretationAudit Documentation MaintenanceProposal Development
Soft Skills
Excellent Written CommunicationExcellent Verbal CommunicationInterpersonal SkillsPresentation SkillsSolution Driven
Certifications & Qualifications
BA Degree
Industry Keywords
Good Clinical PracticeICH GuidelinesCROProject MilestonesInvestigator MeetingsClient ProposalsRFP ResponsesSite ManagementContract BudgetsTraining Plans
About the role
Key responsibilities & impact- Lead UBC project teams to deliver project milestones
- Serve as the primary sponsor contact for study-related items from study start-up through close-out
- Execute operational aspects of assigned project activities and special projects
- Assist with protocols, CRFs, regulatory documents, project master files, and other deliverables
- Develop and monitor communication, monitoring, project, training, compliance, and clinical management plans
- Plan investigator meetings, recruit qualified investigators, and assist with budget negotiations
- Supervise APMs, PMs, and other project team members
- Provide project progress reports to sponsors
- Lead cross-functional projects and supervise supporting functional areas
- Assist with project revenue and invoicing
- Ensure project training occurs and assist with training
- Resolve inquiries involving site management, contract budgets, remediation, and regulatory documents
- Lead internal and client meetings, bid defenses, and project review meetings
- Maintain audit-ready project documentation
- Support sponsor/regulatory audits
- Assist with client proposals and RFP responses
- Track project budgets against contract milestones
- Support protocol, patient/subject consent form, REMS, and REMS supporting document development as required
- Lead process improvement activities and interpret project metrics
- Propose and implement action plans
- Ensure contracted services and milestones are delivered
- Mentor and support APMs/PMs, including issue resolution and client presentation preparation
Requirements
What you’ll need- BA Degree or minimum 5 years of direct project management experience at a CRO or proven leadership/management experience
- Excellent written verbal and non-verbal communication skills
- Excellent supervisory skills
- Excellent interpersonal skills
- Excellent presentation skills
- Ability to independently assess issues and/or mitigate risk by using critical judgment to come to a resolution
- Solution driven
- Manage competing priorities effectively
- Very good knowledge of regulatory requirements (i.e. Good Clinical Practice, ICH guidelines, etc.)
- 10% travel
- Expected project load of 2 to 3 projects depending on scope
Benefits
Comp & perks- Remote opportunities
- Competitive salaries
- Growth opportunities for promotion
- 401K with company match
- Tuition reimbursement
- Flexible work environment
- Discretionary PTO (Paid Time Off)
- Paid Holidays
- Employee assistance programs
- Medical, Dental, and vision coverage
- HSA/FSA
- Telemedicine (Virtual doctor appointments)
- Wellness program
- Adoption assistance
- Short term disability
- Long term disability
- Life insurance
- Discount programs