Lab Manager/Sr. LIMS Project Manager Resume

SUMMARY

Hardworking and dedicated clinical operations enthusiast with comprehensive experience in clinical trial logistics and management. Seeking a dynamic role where I can utilize my unique combination of clinical, analytical and leadership skills.
In depth understanding of scientific concepts, research design and sample management/biobanking
Ethical and Participant Safety Considerations
Drug Development and Regulation
Clinical Trial Operations (GCP/ Confidential /GLP) - Study Management and GCP compliance
Study and Site Management, Sponsor and CRO Management
Data Management Lifecycle - data entry, queries, reconciliation, quality control
Encompasses principles and practice of leadership and professionalism in clinical research
Communication and Teamwork within the site and between the site and sponsor, CRO and regulators as well as a vast understanding of the teamwork skills necessary for conducting a clinical trial

PROFESSIONAL EXPERIENCE

Confidential

Lab Manager/Sr. LIMS Project Manager

Responsibilities:

LIMS System Owner, Administrator and Training Specialist - system implementation, validation, and continuous evaluation to maximize utility across clinical and research
Integrated into all clinical program teams to facilitate optimal sample flow and sample management during study and after completion of study
Company Wide Long-Term Storage Coordinator - ensure transfer of GxP samples to offsite storage vendor, and provide company wide visibility utilizing LIMS platform into offsite storage inventories
Blood Donor Program Coordinator
Confidential Lab Operations Support - sample accessioning and ensuring chain of custody including; sample requests, slide scanning, pathology, reconciliation, data organization, sample destruction, Confidential equipment and resource management
External pathologist and vendor Management
Clinical and Research Biobank Management
Confidential Team interface with research, clinical and IT teams

Confidential

Senior Clinical Research Associate/ LIMS Project Manager

Responsibilities:

Coordinate and Supervise high volume Confidential Laboratory that supports multiple clinical studies (phase I, II and III)
Ensure GxP compliance for multiple functional units and laboratory operations
Develop and support biomarker assay and method validation guidances for various platforms and transfer validated assays into Confidential Lab
Equipment and System Management - management of equipment program with in the Confidential Lab including equipment validation/qualification, Preventative Maintenance and Calibration
Quality Assurance - write, implement and manage quality system documents: SOPs, Quality Incidents, CAPAs, Change Controls, Work Orders
Computerized System Validation – project management, development, validation, system management, implementation, end user training of LIMS system for GxP use
Clinical Trial setup, laboratory logistics, sample management, and data reconciliation – liaise with clinical operations and scientific teams
Clinical protocol and laboratory manual review for phase I, II and III clinical trials
Clinical Site Sample Education and Training on clinical study sample workflow/process requirements

Confidential

Clinical Research Associate

Responsibilities:

Specimen receipt and sample management, chain of custody management, for multiple phase I and II clinical trials
Responsible for oversight and maintenance of multiple trial master files
Implementation of LIMS system, including development, validation, and training
Worked closely with research teams to develop protocols for specimen use and ensuring sample integrity
Maintained strict compliance to SOPs in a high volume Confidential environment
Point of contact in the long term storage initiative including vendor selection, SOP writing and filling requests
Provided clinical trial managers with status updates as well as addressed and rectified specimen queries
Contacted clinical sites directly in order to improve site compliance to specimen processing and handing protocols to ensure the highest quality specimens
Maintained cell lines and created cell pellets for arrays
Tissue Microarray Construction
Antibody Screening and assay optimization for both manual and automated staining
Electronic laboratory notebook (ELN) entry and review