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 http://www.aravive.com.
Job Title: Manager, Clinical Sample Management
Reports to: VP, Translational Medicine
Employment Type: Full-Time
FLSA Status: Exempt
This position is responsible for managing and maintaining the sample management infrastructure and managing sample shipments on a set timeline.
Work will include but is not limited to overseeing daily operations of 3rd party vendors, preparing for internal and regulated audits, creating work instructions and operating procedures (internal and external), and executing sample compliance initiatives as required by regulatory authorities.
This individual will manage operational and logistical aspects of patient sample shipments for global clinical trials, vendor contracting, sample inventory management, and sample disbursement to third party vendors.
- Manage and prioritize daily workflow activities of 3rd party vendor supporting sampling business processes. This includes establishing performance metrics and enforcing accountability of current business rules. Also includes oversight of outsourced project work and ongoing services that require samples.
- Manage global and local shipments of patient serum and tissue 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 and work closely with QA group to promote company compliance.
- Manage samples from multiple clinical trials, technology and software deployments, improvements, and maintenance for all sample management systems.
- Take lead role in sample inventory reconciliation, returns, discrepancies, lost in transit shipments and closeouts. Work closely with central repository to manage inventory in a timely fashion.
- Represent sample operations at stakeholder meetings for ongoing and prospective projects to establish and influence project strategies and deliverables related to samples.
- Manage milestones and timelines across projects, analyze and efficiently communicate project risks and issues as necessary. Proactively 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 timely sample reporting and on-demand support for internal and external parties.
EDUCATION, PREFERRED COMPETENCIES AND SKILLS:
- Bachelor’s degree required
- Minimum five years pharmaceutical or healthcare industry experience with minimum 3 years clinical experience preferred
- 3 + years working in sample operations required
- 2 + years of project management experience preferred
- Experience with international import/export regulations for biologic materials
- Extensive knowledge with Microsoft Office applications is a must (Project, Excel, PowerPoint, Access and Word)
- Organization and time management skills required
- Must possess strong attention to detail and analytical skills
- Proven record of being highly detail oriented
- Excellent references required (minimum 3 – could be managers or subordinates)
- Excellent oral and written communication skills required.
- 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.
- Ability to work remotely but expect global time zones to impact meeting schedules and day to day activities.
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.