Clinical Biospecimen Management Technology Operations Analyst
781 Lincoln Avenue San Rafael, CA 94949
Bayside Solutions is seeking a Clinical Biospecimen Management Technology Operations Analyst to be part of our client’ s team in the North Bay. This is an opportunity to work with the largest privately held pharmaceutical corporation in the world and ranks among the world' s 20 leading pharmaceutical corporations.
Our Client’ s culture is highly collaborative, offers an environment that encourages employees to expand their knowledge in order to make a profound impact on patients’ lives. This could explain why their company has been recognized as one of the “ Top Twenty Employers” in biotechnology and pharmaceuticals by Science Careers.
Our Company Bio: Bayside Solutions was founded in 2001, Bayside was recognized as one of the fastest growing professional staffing companies in Northern California. The numbers tell the story: We have close to a 100% client retention rate, 700% growth in four plus years and over 95% repeat business. Our dedication to building partnership relationships with both our clients and our recruits is the key to our phenomenal success.
You can find additional information on our company website at www.baysidesolutions.com.
Clinical Biospecimen Management Technology Ops Analyst
- An opportunity to join a patient-focused organization that is driven to develop, manufacture and commercialize medicines to treat life threatening conditions.
- Work for a company that is local to the bay area and recognized as a leader of innovation.
- Competitive compensation commensurate with experience.
- This position is eligible for medical, vision, dental benefits, paid sick time, and 401K.
Summary of Responsibilities:
- 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.
Summary of Qualifications:
- H.S. and 6+ related years’ experience or BA degree and 2 – 5 Years’ experience
- 2 years of relevant experience working in the pharmaceutical (including CROs, labs and biorepositories) or related regulated industry
- Individuals in the entry-level CBM Analyst, Systems 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.
- 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
- Individuals should be proficient with Microsoft Office (Excel in particular) and have a basic understanding of database management systems including integration between systems.