A large and quickly growing CRO lab in Indianapolis, Indiana is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. With a relentless focus on quality and innovation, this organization uses its global experience and scientific expertise to transform science and data into actionable medical insights that help customers improve human health.
location: Indianapolis, Indiana
job type: Permanent
salary: $160,000 - 170,000 per year
work hours: 9 to 5
- Oversee the overall operations of the clinical testing function of the laboratory organization. Ensure that laboratory operations meet or exceed all applicable regulatory requirements.
- Ensure that the highest standards of quality and customer service are maintained.
- Collaborate with Quality Assurance staff on development and implementation of effective programs.
- Monitor outside proficiency testing program as required; take corrective action promptly when results are unsatisfactory. Establish effective staff selection and training programs to ensure that qualified staff are hired and continuously trained in order to remain current on testing procedures.
- Ensure that laboratory staff are trained on and comply with safety procedures. Establish and implement procedures to ensure that the physical laboratory environment meet safety requirements.
- Participate in the development and implementation of the department's operating budget. Establish standards for cost control and waste reduction. Monitor utilization patterns of services and advise on developing trends in clinical service needs.
- Keep abreast of new technical developments. Implement new tests, equipment, programs and/or procedures in the department as needed. Lead continuous improvement initiatives to increase quality of services and operational efficiency
- Foster a unified culture and facilitate collaboration, cooperation, sharing of information and teamwork. Lead initiatives to improve employee engagement to positively impact operational results, customer satisfaction and employee retention.
- Manage staff in accordance with organization's policies and applicable regulations. Responsibilities include planning, assigning, and directing work; appraising performance and guiding professional development; rewarding and disciplining employees; addressing employee relations issues and resolving problems. Approve actions on human resources matters.
- Participate in and lead enterprise initiatives such as cross-site governance teams, engagement initiatives, rollout of novel solutions, and cross-site training opportunities
- Support Marketing efforts by preparing materials and information for the purposes of increasing awareness and driving creation of new business
- Represent the business line at national scientific discipline meetings and liaise with Business Development colleagues to drive new business
- Travel with Business Development team members for client-facing meetings, representing the lab in effort to drive new business
- Present capabilities to current and future clients and represent the team for strategic client business review meetings
- Monitor and often lead facilities initiatives such as building expansions, renovations, lease reviews and renewals, etc.
- Oversee and manage Capital Spending plan and budget to meet needs of the business
- Liaise with procurement contacts to manage supply chain and ensure critical supply of reagents and consumable.
- Bachelor's Degree required in science related field. Masters degree or PhD preferred
- 10 years of relevant experience, 3-5 yeas of ADME experience as well as in vitro and metabolite ID experience required or equivalent combination of education and experience
- Minimum of 3 years managing direct staff.
- Prior experience managing customers and contract services is a plus Knowledge, Skills And Abilities
- In depth knowledge of Lab Operations procedures and applicable laboratory testing regulations
- Working knowledge of quality assurance and quality control principles and in depth knowledge of company-specific program requirements
- Knowledge of occupational safety and health rules and regulations - Excellent written and oral communication skills
- Excellent client management and problem resolution skills
- Excellent financial management skills
- Effective mentoring and coaching skills
- High ethical standards
- Strong operational focus
- Ability to motivate a team to achieve shared goals within performance standards and budget
- Ability to assess and prioritize multiple tasks, projects and demands
- Ability to make effective and persuasive presentations on controversial or complex topics to clients
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.