Job Category: Clinical Development
Type: 1-year contract (W2 only) possibility to extend and/or convert!
Pay estimate (DOE): $28 - $38/hr This is an amazing opportunity that can spring board your career and it happens to be onsite at one of our most valued clients!!
We are looking to hire ASAP! Depending on timing, you may need to start remotely but once the stay at home order is lifted, you will be expected to be onsite 5 days a week at the San Rafael location.
*Qualified candidate's are encouraged to submit their resume & cover letter no later than May 15th!!*
Questions to include in your summary/cover letter (You do NOT need to be fancy on this! a few bullet points about each is all we are looking for! ):
1. Please list what types of clinical systems you have used in the past and please rate how knowledgeable you are about each one (scare of 1-5 with 5 being the highest)
2. What Pharma Biotech or CRO companies have you worked at? How long were your there and when were you there (was it recent experience)?
3. What is your direct experience with managing Biospecimens? How many years?
- System User Support
- Assist in performing super user tasks, including but not limited to: updating CBMS: Labmatrix, IT software that tracks study-specific biospecimen inventory and operational workflow information, based on study-relevant documents; gathering and documenting user requirements for adhoc and custom reports; overseeing programming, and generation of reports; performing adhoc queries and working with CBM system vendor(s) as needed to develop queries/reports; loading data from internal & external sources/systems (manual and/or automatic), and flagging issues for other CBM staff or labs/biorepositories for investigation and resolution in order to ensure timely, efficient, high-quality data.
- With CBM Planner, input and maintain all biospecimen-relevant information in CBMS: Labmatrix for clinical trial studies, including: outlining biospecimen stakeholder contacts, number and quantity of each biospecimen collected as related to the study's schedule of events, any unique biospecimen handling or operational requirements, details of testing destinations and related shipping requirements. Ensure that each study is set-up in the CBMS: Labmatrix prior to First Patient In (FPI).
- Collaborate with other CBM staff on biospecimen related logistics, issues and queries.
- With CBMS: Labmatrix system administrator, contribute to vendor related data transfer specifications to determine system compatibility for accurate data tracking ensure accurate biospecimen tracking.
- Assist with internal User Support. Escalate and track support issues as necessary.
- Assist with the development and maintenance of system user manual(s) and training materials.
- System Planning, Design, and Implementation
- Assist with system solution training to CBM staff and other authorized company staff on all CBM Systems related functions
- Support planning and implementation of CBM system enhancements and upgrades as needed. Responsibilities may include: assist in managing and tracking the status of system change requests, enhancements and/or support efforts; perform preliminary impact assessment for requested changes; translate business requirements into solution evaluation criteria and functional design requirements.
- Assist in the development and execution of test plans to ensure the CBM system performs as intended; assist in the execution and documentation of validation testing for changes in database; understand and adhere to computer system validation procedures, partnering with IT
- System Administration
- Act as back-up for application administration activities for CBM systems as needed, including maintaining code lists and libraries, assisting in the development of data transfer plans with laboratories and biorepositories and ensuring they are reviewed appropriately, and implementing system owner approved administrative updates.
- Individuals in the entry-level Systems CBM Analyst, role are expected to demonstrate good foundational Communication, Planning, Prioritization and Organization, Proactivity, and Teamwork skills in order to quickly integrate into the team-based, cross-functional culture.
- This includes:
- sharing ideas and work product with competence in a clear, concise, and timely way
- effectively participating in small functional meetings
- adeptly identifying critical path tasks and consistently delivering on time and as expected quickly developing and maintaining strong working relationships
- modeling a fair, transparent and collaborative approach to work execution the analyst will also focus on developing key core competencies such as Leadership, Problem Solving, and Influence and Persuasion.
- The Analyst will also strive to develop the critical technical skills necessary for success on the CBM team, including Biospecimen Management Processes and Logistics and Good Practices and Compliance
- H.S. and 6+ related years’ experience OR BA degree and 2-5 Years’ experience
- 2 years of relevant experience working with clinical systems within in the pharmaceutical (including CROs, labs and biorepositories) or highly regulated environment
- Individuals should be proficient with Microsoft Office (Excel in particular) and have a basic understanding of database management systems including integration between systems.