Address
Form of workJob Description
- Work with relevant internal team members from TM, Clinical Development, Clinical Operations, DMPK, Data Management, Quality Assurance, and external vendors to assist in the coordination of sample shipments, data analysis, clinical data transfers, sample/data reconciliation and data review.
- Monitor and assist in the maintenance and optimization of key clinical patient biomarker molecular profiling and study specimen recordkeeping resources.
- Assist in authoring and/or reviewing relevant sections of clinical study protocols, laboratory manuals and other relevant study manuals/plans pertaining to the collection, processing, shipment, and storage of clinical study specimens.
- Working with TM and Clinical Operations team members to initiate and finalize specialty lab vendor contracts/SOWs, manage POs, approve, and archive invoices in support of clinical study objectives and TM biomarker profiling goals.
- Work with Quality Assurance team members to implement and oversee quality metrics around site performance and compliance, sample processing and data deliverables.
- Work closely with Clinical Operations team members to align clinical study timelines and deliverables, attending regular meetings as TM support/representative.
- Support the ongoing development of Discovery-wide operational initiatives including website content maintenance, sample tracking process improvements, and data storage structure planning.
- Contribute to the strategy and tactics of PO and Contract submission processes for the Discovery organization including data entry, communication, tracking, and efficiency improvements.
- Participate in Research Operations project development efforts by contributing to information gathering, brainstorming, and tool / process creation.
- Join TMIR (Translational Medicine and Integrated Research) team meetings and contribute to team discussions and team goals.
Requirements / Qualifications:
- Bachelor of Science degree.
- 3-5 years of relevant industry experience, preferably in the Clinical Operations space
- Experience with project management and sample tracking methods and tools such as Smartsheet, Excel, etc.
- Experience with monitoring clinical study specimen collection, handling, storage, and inventorying a plus.
- Sample clinical and pre-clinical accessioning experience
- Experience working with human patient biomarkers and common clinical technologies used for profiling them, including NGS, qPCR, IHC, MSD, NanoString, etc., a plus.
- Exceptional organizational and recordkeeping skillsets, with strong attention to detail.
- Strong team player, with good communication skills.
Skills: Required
- CLINICAL OPERATIONS
- DATA MANAGEMENT
- DATA ENTRY
- PROJECT MANAGEMENT
- PROCESS IMPROVEMENTS
Additional
- CONTINUOUS PROCESS IMPROVEMENTS
- TEAM PLAYER
- MAINTENANCE
- OPERATIONS
- POINT OF SALE
- INVOICES
- LABORATORY
- PRECLINICAL
- METRICS
- EXCEL
- SMART SHEET
- RECONCILIATION
- DATA ANALYSIS
- MARKETING ANALYSIS
- COLLECTION
- CLINICAL STUDY
- QUALITY ASSURANCE
- CONTRACTS
The Steely Group is a national preclinical, clinical, and commercial staffing firm and certified women’s business enterprise. We partner with small, growing biotech, pharma, and gene therapy companies to help bring treatments to patients by providing flexible talent acquisition solutions including Contingent Search (Direct Hire & Contract Consultants) and Retained Executive Search.
