We provide IT Staff Augmentation Services!

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

Hire Now