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Senior Project Manager
Precision Medicine Group. Plan, direct, coordinate and deliver activities for designated clinical study projects to meet quality, scope, cost and time objectives .
Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates extensive experience in clinical project management, including budget management, risk mitigation, and compliance with ICH-GCP standards. Proven ability to lead cross-functional teams and communicate effectively with clients and stakeholders.
Highest-signal resume keywords
Clinical Research ExperienceProject Management ExperienceBudget ManagementICH-GCP KnowledgePresentation 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 PlanningRisk ManagementChange ManagementAnalytical SkillsNegotiation SkillsDecision-Making SkillsTime ManagementAttention to DetailCustomer Service SkillsInterpersonal Skills
Soft Skills
Communication SkillsOrganizational SkillsLeadership SkillsTeam CollaborationCritical Thinking
Tools & Technologies
Microsoft Office ProductsMicrosoft ProjectETMFEDCCTMS
Industry Keywords
Pharmaceutical ResearchDevice ResearchOncologyCell TherapyGene Therapy
About the role
Key responsibilities & impact- Plan, direct, coordinate and deliver activities for designated clinical study projects to meet quality, scope, cost and time objectives
- Serve as primary point of contact and escalation point for clients
- Coordinate and oversee functional services and external vendors against timelines and budgets
- Manage study budgets, scope, out-of-scope activities, financial health, profitability, billable hours, billing and forecasting
- Collaborate with clinical operations and functional teams in study delivery and clinical activities
- Develop comprehensive project plans, timelines and proactive risk mitigation strategies
- Ensure project quality, eTMF inspection readiness, quality notifications and corrective/preventive action plans
- Establish tracking metrics for trial and team progress
- Prepare project status updates and report KPIs and progress to clients and senior management
- Lead internal and client meetings and set project-team expectations
- Communicate protocol and study issues, deviations and required actions
- Conduct formal presentations, including bid defenses
- Implement and monitor study-specific training compliance
- Support business development and marketing activities, including travel to bid-defense meetings
- Provide ongoing feedback and annual performance reviews for functional team members
- Complete assigned duties, organizational training, time reporting and administrative requirements
Requirements
What you’ll need- North America: Bachelor’s degree or equivalent combination of education/experience in science or health-related field; advanced degree preferred
- EU: Degree or equivalent combination of education/experience in science or health-related field; advanced degree preferred
- Minimum of 7 years of clinical research experience or proven competencies for this position
- Minimum of 4 years of direct project management experience
- Experience managing complex and global trials
- Ability to travel domestically and internationally, including overnight stays
- Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint), Microsoft Project, eTMF, EDC and CTMS
- Proven communication and interpersonal skills to effectively interface with others in a team setting
- Proven organizational skills, attention to detail, and a customer service demeanor
- Knowledge of ICH-GCP and relevant Precision SOPs, with ability to implement them
- Direct work experience in a global, cross-functional project management environment
- Good understanding of cross-functional management
- Good understanding of project planning, risk management and change management with awareness of appropriate escalation
- Proven experience in strategic planning, risk management and change management
- High level of integrity and professional and ethical standards
- Ability to lead and inspire excellence within a study team
- Proven time management, negotiation, critical thinking, decision-making, analytical and interpersonal skills
- Proven presentation, verbal and written communication skills
- Good understanding of project management software
- In-depth proven experience in pharmaceutical and/or device research required
- Experience with oncology and cell and/or gene therapy preferred
- Must be legally authorized to work in the country of employment without employer sponsorship
Benefits
Comp & perks- Discretionary annual bonus
- Health insurance
- Retirement savings benefits
- Life insurance
- Disability benefits
- Parental leave
- Paid time off for sick leave and vacation