Provide day-to-day direction of staff and manage the Client Delivery Team to achieve client and company goals and/or initiatives; Support direct reports and drive continuous improvement in processes and procedures used by the project team; Perform duties and responsibilities of Project Manager when needed, for short-term or long-term assignments.

Manage the process of designing and launching global/regional clinical research studies under general direction; lead activities of the Sponsor/Clinical Research Organization (CRO), and guide the Project Manager (PM) and Set-up Coordinators (SC) in designing and organizing project components.Prepare source documents for protocol specific clinical trial lab database setup, configure, QC and test database.

Setup, configure, QC, and test clinical trial databases

Setup, configure, QC, and test clinical trial databases

Audited over 1,000 data points to verify appropriate documentation was present for required sites, methods, and equipment.Process, log, and track clinical study documents in accordance with CRF Tracking and Data Entry Guidelines.Use validated software to design and maintain data integrity for release to production.Process and enter data accurately and in a timely fashion.Assist in the maintenance of Data Management Study files.Develop and maintain good communications and working relationships within CDM team.Review and approve deliverables (outputs) as required by process.Participant in system validation activitiesTest Code Creation, Review, and Auditing within StarLIMS and QLIMS.Manage departmental spreadsheet for tracking and metrics

Developed new system of documenting in logbooks in addition to new format for logbooks across departments. Participant in monthly review of documents. Participant in capacity studies and aseptic protocol validation. Trained incoming personnel on Standard Operating Procedures.Aseptically manufacture and assemble commercial human blood derived components in a clean-room environment (Class 10,000/ISO5 and Class 100,000/ISO7)Weigh, measure, and allocate materials to ensure properly manufactured batchesMaintain records and clean room environment to comply with regulatory requirements, good manufacturing practices and aseptic processing of clinical and commercial products using Standard Operating ProceduresReview batch records and logbooks to ensure accuracy and completeness prior to QA final reviewInvestigate deviations to determine impact, root cause, and corrective measuresCompose and submit reports (i.e. shift report, schedule, etc.) throughout department and upper management teamRepresent department in cross-functional teams, projects and GXP related problem resolution.

Performed a full range of clerical and technical duties in support of the Forensic Toxicology Drug Testing Laboratory. Served as Acting Team Lead in absence of supervisorReceived and handled specimens including completion of chain of custody forms. Analyzed, sorted, and made determinations about accepting or rejecting specimens. Assured identification of each specimen was accurate and complete, entered demographic information into the computer, and assigned laboratory accession number to specimens.Prepared and aliquoted specimens for initial and confirmation testing.Segregated suspected positive specimens for screening batches in accordance with verification procedures

Developed a system for monitoring patients for distant follow-up appointmentsAssisted physicians for in-office clinic, including reviewing charts for completeness, Scheduled patient’s surgeries, referrals, and ordered laboratory and radiology tests. Cleaned and sterilized instruments and prepared surgical packs using aseptic technique.Performed wound care to include staple and suture removal, debridement, and KCI vac applicationNotified pharmacies via phone and fax of new prescriptions and refills