Jennifer Kalamatas
IL
Summary
Collaborative clinical manager with over 12 years hands on clinical laboratory and diagnostic device experience serving the pharmaceutical, biotechnology and medical device industries. Clear communicator passionate about people leadership who is driven to lead individuals to meet project and individual performance goals. Meticulous planner with an eye for detail to maintain integrity of study deliverables and meet project milestones. Well versed in clinical project management including clinical trial operations, regulations and change management.
Overview
12
12
years of professional experience
Work History
Clinical Affairs Manager
Beckman Coulter Diagnostics
Chaska, MN
03.2023 - Current
- Led a team of clinical affairs associates, emphasizing the importance of collaboration and teamwork to drive progress and achieve company goals.
- Evaluated study progress to pinpoint potential risks or delays, implementing strategic solutions to mitigate them.
- Reviewed and prepared clinical study documents for approval by regulatory bodies.
- Successfully facilitated cross-functional collaboration with regulatory affairs, research and development, data management, product management,and biostatistics teams for the timely completion of projects.
Clincal Project Manager
Beckman Coulter Diagnostics
Chaska, MN
04.2022 - 03.2023
- Generated timelines for protocol development, database lock, submission filing activities, and other milestones.
- Formulated and executed project plans, ensuring prompt completion of clinical trials.
- Implemented proactive measures based on observed site performance metrics.
- Performed clinical study data monitoring for testing studies in accordance with Good Clinical Practice and Good Laboratory Practice.
- Guided and supported senior clinical research associates and clinical project managers in a formal mentorship during their onboarding process into the clinical affairs team.
- Management of external customer and vendor relationships with effective, documented communication including study budget negotiations, contract amendments and supply purchase requisitions.
- Led biorepository operations through vendor management, preparation and review of sample shipments, scheduling and ensuring proper reconciliation of test samples provided to clinical testing sites.
- Aided core team leadership in ensuring timely completion of critical deliverables and study outputs across clinical operations.
- Produced and revised clinical study protocols, monitoring plans, reports, and other study documents to generate high-quality study data and final study reports.
Laboratory Manager, Specialty Studies
IHMA
Schaumburg, IL
10.2018 - 03.2022
- Managed team of up to seven skilled microbiologists and laboratory assistants, guiding them towards achieving performance targets through individual goal setting and fostering growth as a people leader and mentor for four years.
- Demonstrated strong leadership by efficiently coordinating tasks, schedules, and assignments for a multidisciplinary laboratory team.
- Successfully collaborated with external department teams including Data management, Executive team, and Project Management to achieve study goals and meet challenging timelines at a high throughput central laboratory.
- Managed early drug discovery, diagnostic device studies and clinical trials for the pharmaceutical, in vitro diagnostic and biotechnology industries as the Specialty Studies Project Manager.
- Organized processes and maintained complete records for each study, including data reporting forms, quality control, study data and final study reports.
- Verified accuracy of data, completeness of information, and reported on each case by coordinating with data management.
- Managed studies with integrity, prioritizing protocol and sponsor expectations by creating study-specific laboratory instructions and SOPs for clear instruction to the laboratory.
- Efficiently managed a large-scale isolate repository containing over 1 million bacterial isolates. Responsibilities included equipment maintenance, coordinating sample reception/shipping, and seamless integration into a LIMS system.
Microbiologist I
IHM
Schaumburg, IL
09.2012 - 10.2018
- Conducted routine microbiology assays, including antimicrobial susceptibility testing, according to SOPs.
- Maintained laboratory equipment with daily cleaning, upkeep, and preventive care.
- Maintained consistent communication with supervisors, reporting any observed deviations or nonconformities in test results.
- Maintained precise record-keeping by inputting results into laboratory information systems with meticulous attention to detail.
- Organized files and records and handled other support tasks, freeing up managers to take on more pressing responsibilities.
Education
Master of Science - Biology
Roosevelt Altern School
Chicago, IL05-2012
Bachelor of Science - Biological Sciences
Northern Illinois University
DeKalb05-2010
Skills
- People Leadership and Mentoring
- Clinical Research & Data Monitoring
- Clinical Study Management
- Clinical Study Protocol Development
- Sample Procurement & Chain of Custody
Timeline
Clinical Affairs Manager
Beckman Coulter Diagnostics
03.2023 - Current
Clincal Project Manager
Beckman Coulter Diagnostics
04.2022 - 03.2023
Laboratory Manager, Specialty Studies
IHMA
10.2018 - 03.2022
Microbiologist I
IHM
09.2012 - 10.2018
Master of Science - Biology
Roosevelt Altern School
Bachelor of Science - Biological Sciences
Northern Illinois University