Coordinator, Clinical Biospecimen
Marin Metro Area, CA
Process Improvement Leadership:
Support Clinical Biospecimen Management Process Improvement efforts, as delegated, such as:
- Partner or consult with individuals, teams, and cross-functional working groups to conduct process analysis in order to identify process gaps and develop actionable response strategies.
- Apply continuous improvement tools and methodologies, such as root cause analysis, process mapping, RACI, lessons learned, and Voice of the Customer analysis to business problems in order to drive efficiency and effectiveness.
- Partner with teams and functions to develop optimized business processes, process improvements and change initiatives that meet business needs and support achievement specific CBM goals and objectives as well as the larger Developmental Sciences goals and objectives.
- Facilitate the development, implementation, and tracking of appropriate change management and process improvement metrics.
- Analyze and interpret metrics, financial data, and human resources data to provide business insights, charter new cross-functional initiatives, make data-driven process improvement decisions and assess impact of completed improvements.
- Proactively research, learn and apply best practice process improvement techniques and tools.
Contribute to/and or support Clinical Biospecimen Management Process Improvement activities, as delegated, such as:
- Ensure process improvement projects are tracking to key deliverable and milestone timelines.
- Act as a liaison between project teams, management, and technology management groups for process improvement initiatives and analytics.
- Support process development for metrics reporting, dashboards, and related tools.
- Organize and facilitate cross-functional project team meetings, including development of agendas, documentation of action items and communication of outcomes.
- Communicate project objectives, plans and timelines and status to the cross-functional teams.
- Address roadblocks issues and/or risks to process improvement initiatives, including assessing alternative approaches and communicating timeline or resource adjustments.
- Ensure process improvement and change management programs are executed on time and with high quality output.
- Lead small CBM operational and functional improvement projects.
- Assist in managing CBM Core Working Group activities, i.e., taking meeting minutes and assisting in the following up of action items.
- The Coordinator also works closely with a range of cross-functional groups within Development Sciences and beyond, including Clinical Operations, Data Management, Legal, Compliance, Translational Sciences, IT, Technical
A Coordinator demonstrates good foundational competence in several CBM core competencies such as communication, problem solving, decision making and teamwork including:
- Sharing ideas and work product with competence in a clear, concise, and timely way
- Effectively facilitating small functional meetings
- Adeptly identifying critical path tasks and consistently delivering on time as expected
- Developing and maintaining strong working relationships
- Modeling a fair, transparent and collaborative approach to work execution
- Familiarity working with cross-functional study teams that manage clinical trial protocols and the challenges that occur during all phases of drug development.
- Familiarity with biospecimen management and biospecimen inventory tracking as related to clinical trial protocols, laboratory manuals and vendor s contract statement of work is a plus.
- Familiarity and competency in the use of data inventory systems, i.e., LabMatrix, to track and perform key biospecimen-related operational activities is a plus.
- BA/BS in life sciences, engineering or related degree
- 1 year of relevant pharmaceutical industry experience in process improvement or equivalent role
- Lean Six Sigma Green Belt