8230 Senior Manager, Clinical Laboratory & Biospecimen Management Process Improvement
Process Improvement Leadership:
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 CLBM goals and objectives as well as the larger DSO 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.
Support junior CLBM team members in building a knowledge base of formal Process Improvement methodologies and common tools through training, consulting, and mentorship; offer expert guidance on process designing and improvement best practices, tools, processes, and governance policies.
Promote and advocate the importance of process design, process optimization and change management in the CLBM organization and other parts of DSO.
Proactively research, learn and apply best practice process improvement techniques and tools.
Process Improvement Initiative Execution:
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.
Lead 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 CLBM operational and functional improvement projects.
Assist in managing CLBM Core Working Group activities, i.e., taking meeting minutes and assisting in the following-up of action items.
The Senior Manager also works closely with a range of cross-functional groups within DSO and beyond, including Clinical Operations, Data Management, Legal, Compliance, Translational Sciences, IT, Technical Operations and across the Company.
A Senior Manager has a leadership role in key organization-wide process improvement initiatives and may have the opportunity to manage junior staff.
A Senior Manager demonstrates advanced competence in several CLBM core competencies such as communication, problem solving, decision making and teamwork including:
Ability to distill complex issues and topics into simple terms for improved stakeholder clarity and understanding.
Ability to look beyond the obvious and focus on finding innovative solutions.
Create an inclusive, supportive team culture.
Familiarity with biospecimen management and biospecimen inventory tracking as related to clinical trial protocols, laboratory manuals and vendor’s contract statement of work.
Familiarity and competency in the use of data inventory systems, i.e., LabMatrix, to track and perform key biospecimen-related operational activities.
Familiarity working with cross-functional study teams that manage clinical trial protocols and the challenges that occur during all phases of drug development.
The Senior Manager is also demonstrating advanced technical competency in process improvement, project management and change management, as well as foundational skills in strategic planning and drug development, including:
Actively manage project tradeoffs involving scope, timing and resources.
Exhibit expertise in formal process improvement methodologies such as Kaizen, Lean, Six Sigma.
Help project stakeholders understand and plan for the impact of change on the organization.
Demonstrate familiarity with strategic planning tools such as value mapping and can take a complete organization perspective when planning for improvement initiatives.
Needs to have at least 8 years of relevant pharmaceutical industry experience in process improvement or equivalent role.
Project Management or Process Improvement certification a plus.
BA/BS in life sciences, engineering or related degree Six Sigma Black Belt Lean Six Sigma Green Belt Certificate.
PLEASE NOTE: Our client has mandated COVID-19 vaccination for their workforce, all external personnel providing services to our client are required to comply with this requirement.