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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in managing clinical trials, including project financials, regulatory compliance, and cross-functional team leadership. Proficient in risk management and project performance monitoring throughout the study life cycle.
Highest-signal resume keywords
Project Management ExperienceClinical Trials CoordinationKnowledge of ICH-GCPBudget ManagementCross-Functional Team Leadership
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 ManagementClinical Trials ManagementBudget ManagementRisk ManagementData CleaningSOP DevelopmentStudy Start-Up ActivitiesContract ReviewRegulatory Authority ApprovalsCTMS Tracking
Soft Skills
CommunicationLeadershipProblem-SolvingTrainingCollaboration
Tools & Technologies
Microsoft OfficeProject Management Systems
Industry Keywords
Pharmaceutical Industry RegulationsSponsor Relationship ManagementAudit PreparationStudy Life Cycle ManagementSite Selection
About the role
Key responsibilities & impact- Own the sponsor relationship and serve as the central point of contact and escalation
- Communicate project progress, risks, and solutions
- Lead sponsor and project team meetings
- Contribute to pre-award strategy, project management strategies, Bid Defense, and handover meetings
- Lead study start-up activities, including site selection, contract and budget review, team and system setup, and IRB/EC and regulatory authority approvals
- Direct internal and sponsor kick-off meetings
- Lead clinical trials or programs through completion within budget and schedule
- Monitor study timelines, recruitment, retention, data cleaning, project performance, and CTMS tracking
- Manage project financials, including budgets, revenue recognition, milestone payments, and pass-through invoices
- Prepare projects for audits and inspections
- Oversee administrative closeout and document archiving
- Lead end-of-study lessons learned meetings
- Identify risks, develop contingency plans, and mitigate issues throughout the study life cycle
- Contribute to SOP development
- Provide oversight and training to Associate Project Managers and Project Assistants
Requirements
What you’ll need- Bachelor's degree in a science-related field
- 2 years of Project Management experience with Parexel or 3 to 5 years of experience in related fields
- Early phase experience; site level experience is highly preferred
- Experience as a Functional Team Leader or in coordinating clinical trials
- Knowledge of ICH-GCP and pharmaceutical industry regulations
- Proficiency in Microsoft Office products
- Ability to lead cross-functional Parexel and sponsor teams
- Ability to manage priorities, risks, escalations, and solutions across the study life cycle
- Experience managing project systems, operational metrics, contracts, budgets, and financial processes
Benefits
Comp & perks- Health, Vision & Dental Insurance
- Tuition Reimbursement
- Vacation/Holiday/Sick Time
- Flexible Spending & Health Savings Accounts
- Work/Life Balance
- 401(k) with Company match
- Pet Insurance
- Paid time off
- Life insurance
- Additional benefit offerings in accordance with applicable plans
