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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in clinical supply chain management, project management, and regulatory compliance, with a strong focus on risk analysis and mitigation strategies. Proficient in utilizing various supply chain systems and tools to optimize clinical supply activities and ensure adherence to Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).
Highest-signal resume keywords
Project ManagementClinical Supply Chain ManagementRisk Analysis and MitigationSupply Chain Systems ProficiencyRegulatory Compliance
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 Management PrinciplesSupply Chain PlanningDemand PlanningAnalytical Problem-SolvingClinical Documentation AuthoringChange Control ProcessingInventory ManagementForecastingClinical Trial ProtocolsSupply Chain Operations
Soft Skills
Excellent CommunicationInterpersonal SkillsNegotiation SkillsRelationship BuildingAttention to Detail
Tools & Technologies
SAPMicrosoft PowerAppsIRTVeevaMicrosoft ExcelMicrosoft PowerPointMicrosoft WordSWMSMyLearningERP Systems
Industry Keywords
Good Manufacturing Practices (GMP)Good Clinical Practices (GCP)Clinical Supply ActivitiesSupply Chain MetricsRegulatory Agency InspectionsClinical DevelopmentQuality AssuranceSOP DevelopmentChange ControlsDocument Control
Tech Stack
Tools & technologiesERPOracle
About the role
Key responsibilities & impact- Design strategic and operational plans for clinical supply activities for assigned studies
- Serve as the primary GCS point of contact for internal and external stakeholders
- Represent GCS at Clinical Trial Teams and product development meetings
- Collaborate with clinical development, regulatory, quality, and supply chain organizations
- Establish timelines for clinical supply needs and provide sourcing, manufacturing, packaging, and distribution signals
- Analyze clinical study supply-chain risks and develop mitigation strategies
- Use IRT, Microsoft PowerApps, SWMS, Veeva, MEDS, MyLearning, Microsoft applications, and SAP to manage clinical supplies
- Establish consolidated forecasts for bulk drug product and clinical finished goods
- Author clinical supply, labeling, packaging, supply-chain, and CMC documentation
- Author the Clinical Supplies section of study protocols
- Prepare and present clinical supplies information at Investigator Meetings
- Support collection of clinical supply chain metrics and critical non-pipeline activities
- Participate in IVR system development and UAT
- Initiate and process change controls, deviations, and deviation investigations
- Support process improvement initiatives, SOP/BP development and maintenance, and cross-functional projects
- Support regulatory agency inspections for assigned trials
- Solve unstructured problems, make informed risk decisions, and influence portfolio decisions using facts and data
Requirements
What you’ll need- Bachelor’s Degree in scientific, business, or related discipline required
- At least 5 years of experience in project management
- At least 5 years of experience in planning, scheduling, coordination and processing of supply chain activities, or the equivalent
- Excellent communication and interpersonal skills
- Strong negotiation, influencing, and relationship-building skills
- Strong knowledge of project management principles and clinical customer relationship management
- Familiarity with supply chain systems and software, such as SAP or Oracle
- Knowledge of demand planning principles
- Proficiency in Microsoft Excel, PowerPoint, and Word
- Strong analytical and problem-solving skills
- Ability to adapt quickly to changing business needs and priorities
- Strong attention to detail and organizational skills
- Proficiency in supply chain management systems, ERP systems, demand planning tools, and inventory management systems
- Proven record in project/portfolio management
- Knowledge of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) highly desirable
- Knowledge of order management, supply chain operations, and document control
- No visa sponsorship
- US and Puerto Rico residents only
Benefits
Comp & perks- Annual bonus
- Long-term incentive, if applicable
- Medical, dental, and vision healthcare
- Other insurance benefits for employee and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Hybrid work arrangement
- 10% travel
