Summary of Position: This position is responsible for managing global investigational drug supplies and managing the Bio-sample management infrastructure on a set timeline and in compliance to Good Clinical Practices.
Work will include but is not limited to overseeing daily operations of 3rd party vendors, creating work instructions and operating procedures (internal and external), and executing Bio-sample and investigational drug supply initiatives.
This individual will manage operational aspects of drug shipping, vendor contracting, sample receipts, distribution and accountability from multiple labs and clinical sites around the globe. He/she builds relationships with and acts as a key resource and escalation point for study teams, distributors, and suppliers and contributes to the creation of strategy for clinical drug supply and sample management; translates strategic objectives into plans for team execution. Works within clinical study teams as well as cross-functionally to develop consistent practices.
Knowledgeable of departmental and pharmaceutical industry best practices including Good Clinical Practices, Good Manufacturing Practices and Good Laboratory Practices. Develop manufacturing/inventory planning based on study demand. Routinely identify risks in supply chain, recommend mitigation plans to management, and implement solutions.
Ensure resources are in place to support clinical studies and supply chain projects. Manage/support cross-functional projects such as cross-functional process/system integration. Build processes that are scalable for future growth.
Job Title: Senior Manager, Clinical Supply Chain
Reports to: Vice President, Clinical Operations
Employment Type: Full-Time
FLSA Status: Exempt
Date: Fall/Winter 2020
- Manage and prioritize daily workflow activities of 3rd party vendors supporting clinical study drug supply and clinical sample collection and processing. This includes oversight of outsourced project work
- Day-to- day oversight of global and local shipments of Investigational drugs and clinical Bio-samples
- Develop and implement Standard Operating Procedures (SOPs) and work instructions that ensure full compliance with protocols in place
- Manage sample operations for audit readiness
- Manage multiple complex projects, business process development and technology and software deployments, improvements, and maintenance for all sample management systems.
- Take lead role in inventory reconciliation, returns, discrepancies, lost in transit shipments, complaints, recalls and closeouts.
- Represent sample operations at stakeholder meetings for ongoing and prospective projects to establish and influence project strategies and deliverables related to samples. Stakeholders to include internal teams, Sponsor meetings, etc.
- Manage milestones and timelines across projects, analyzes and communicates project risks and issues as necessary. Adjust project plans, timelines or resources to ensure successful project delivery.
- Assist in contract processes in conjunction with Project Directors in providing correct scope of work for initial contracts and identifying changes in scope in ongoing projects
- Provide sample reporting and on-demand support for field sales, 3rd party vendors and internal customers.
Education, Behavioral Competencies and Skills:
- Bachelor’s degree required
- Minimum five years relevant pharmaceutical experience required
- 5 + years working in sample operations/accountability/compliance
- 5 + years of clinical drug supply oversight experience
- Experience with international import/export regulations for biologic materials
- Experienced Investigational drug supply chain management
- Trained on GCPs required, and GMP, GLPs desired
- Experience with packaging/ labeling of investigational drug supplies required
- Experience with IVRS, IRT setup
- Experience with Oracle EDC software preferred.
- Experience with sample management software and Microsoft project
- Extensive knowledge with Microsoft Office applications is a must (Project, Excel, PowerPoint, Access and Word)
- Smartsheet experience desired.
- Organization and time management skills required
- Possesses strong attention to detail and analytical skills
- Proven record of being detail oriented, possessing accuracy, and understanding quantitative issues.
- Excellent analytical and technical skills.
- Excellent oral and written communication skills.
- Ability to multi-task.
- Excellent problem-solving skills with consistent demonstration of sound judgment required.
- Experience managing business operations and/or processes very desirable.
- Strong understanding of auditing principles desired.
- Medical, Dental, Vision, 401(k)
Aravive, Inc. is an Affirmative Action/Equal Opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, protected veteran status, national origin, disability, sexual orientation, gender identity, marital status, genetic information or any other characteristic protected by law.
Company Overview: Aravive, Inc. is developing treatments designed to halt progression of life-threatening diseases, including cancer. Our approach draws on novel insights into targeting signaling pathways that drive the activation, migration and invasion of abnormal cells into healthy tissues. The company is based in Houston, Texas, and received support from the Cancer Prevention & Research Institute of Texas (CPRIT). For more information, please visit our website at https://aravive.wpengine.com.
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