Analyst, Clinical Biospecimen Management Technology Operations
BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind.
BioMarin’s Research & Development group is responsible for everything from research and discovery to post-market clinical development. Research & Development involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases. Come join our team and make a meaningful impact on patients’ lives.
System User Support
- Assist in performing super user tasks, including but not limited to: updating CBMS: Labmatrix, BioMarin’s 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
- 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 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 BioMarin 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
Individuals should be proficient with Microsoft Office (Excel in particular) and have a basic understanding of database management systems including integration between systems.
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
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.