Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research development and delivery of life-changing therapies. With clinical trials conducted in 100 countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio our work spans laboratory digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on now and in the future.
Location/Division Specific Information
Our Early Development team focuses on Phase I and IB trials which represent the first practical tests of a compounds clinical relevance and commercial viability. They are the culmination of years or even decades of research. Moreover they set the stage for subsequent studies that will ultimately determine your compounds efficacy safety and positive impact on patients lives.
Discover Impactful Work:
Manages a team within the Laboratory department. Processes and ships study specimens according tostudy protocol. Oversees department compliance with organizational policies and procedures as well asGood Clinical Practice/ICH GDP OSHA and CIA or CLIA-waived guidelines and local regulatory guidelines.
A day in the Life:
- Manages staff which may include interviewing and selection job descriptionpreparation professional development goal setting performance managementcoaching and mentoring employee counseling and separations. Approvescourses of action on salary administration hiring corrective action andterminations. Reviews and approves time records expense reports requests forleave and overtime.
- Forecasts and manages all functions of the early phase clinical and PKLaboratory. Contributes to the development and maintenance of procedures andpolicies to support optimization of operations.
- Projects staffing requirements. Assures that the training needs and requirementsof laboratory are met.
- Arranges and projects the activities methods and procedures of the samplecollection to ensure proper specimen integrity and shipping are successfullyattained.
- Plans the development implementation and continuous monitoring of a qualityimprovement plan for the group.
Keys to Success:
Education and Experience:
- Previous experience that provides the knowledge skills and abilities to perform the job (comparable to5 years) or equivalent and relevant combination of education training & experience.
- 1 year of leadership responsibility
Knowledge Skills Abilities
- Good knowledge of CLIA CAP and FDA regulations
- Strong leadership skills including ability to motivate mentor and train
- Advanced written and verbal communication skills
- Strong time management organizational and multi-tasking skills
- Solid critical thinking problem-solving and troubleshooting skills
- Proficient in Microsoft Office products
- Ability to work in a collaborative team environment
- Strong knowledge of operational laboratory instrumentation
- Good knowledge of special handling and processing of specimens
- Advanced knowledge of operating laboratory instrumentation
- Good understanding of budgeting and forecasting with the ability to interpret data with attention todetail and analytical and investigative skills
- Capable of driving innovation in developing new ideas related to process improvements
- Excellent communication skills with Czech and English
Required Experience:
Manager