Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000 xxx-xxx-xxxx ● abc@xyz.com

Clinical Studies ~ Scientific Research ~ Project Management ~ Regulatory Compliance

         Well-versed in engineering services compliance metrics including non-conformances, CAPAs, work orders, training, and safety rules, practices, and protocols.

         Advanced knowledge of cGMP regulations and latest validation guidelines.

         Solid background in project leadership, statistical data collection and analysis, ICD-9 audits, gap analysis, variance analysis, clinical documentation, and clinical quality assurance.

         Able to conduct detailed technical investigations including root cause analysis and CAPAs to prevent reoccurrence of non-conformances.

         Thorough knowledge of compounding, filling, and packaging processes within pharmaceutical industry.

         Strong expertise in Good Clinical Practice (GCP) CRF, DCF, EDC, and safety compliance.

Bausch & Lomb, Tampa, FL, 2017 Present

Validation Engineer (Contractor)

         Design, implement, and execute protocols to validate manufacturing equipment, facilities, utilities, and computerized systems according to latest cGMP, FDA, and BLP guidelines.

         Supervise, mentor, and direct contracted and/or temporary employees in validation activities while emphasizing rigorous compliance with environmental health and safety procedures and cGMP criteria.

         Methodically assess and conduct process/equipment/systems re-qualifications to ensure constant validation for manufacturing of sterile pharmaceutical products.

         Govern project planning, coordination, and management for CIP/compliance-related projects as required.

         Gather pertinent documentation for completing validation tasks, systematically evaluate test data, and author final reports to summarize testing results.

         Meticulously audit final reports to verify adherence to SOPs, cGMP, ISO, QA/QC, and CFR statutes.

Self-employed, 2015 Present

Principal Consultant / CEO / Founder

         Provide highest-quality medical equipment and clinical consulting services on a global scale.

         Partner with cross-functional teams to plan, implement, evaluate, and deliver projects spanning telemedicine, clinical quality assurance, policy development, and access to medical care.

         Currently orchestrating projects serving West Africa including construction of 200-bed orphanage facility, public health initiatives (i.e. HIV awareness, clean water), and renewable energy solutions such as construction of 50 solar homes.

ProPhase, New York, NY, 2014 2015

Clinical Quality Assurance Administrative Officer

         Spearheaded clinical QA projects encompassing data collection, trend analysis, bids, purchase requisitions, database administration, budget compliance, progress tracking, and report writing.

         Assembled critical validation lifecycle documentation for equipment, processes, and facilities such as IQ, OQ and PQ protocols, SOPs, change controls, and user/functional/design specifications.

         Contributed to creation of algorithms to identify actionable patient-specific opportunities for strengthening compliance with best clinical practice.

         Calculated estimates for executive team, oversaw validation vendors, maintained quality systems, guided project workflow, and improved accuracy of budgeted hours to fuel company capacity and profit.

         Provide cGxP compliance interpretation, consultation, and training to elevate quality of research.

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Yale Cancer Center, New Haven, CT, 2011 2014

Interim Project Manager / Data Manager

         Governed clinical study documents including clinical protocols, informed consent forms, study plans, case report forms, source documents, monitoring plans, data management plan, and project management plan.

         Exhibited outstanding talents throughout the project lifecycle from defining timelines and tracking status, to communicating progress to stakeholders and providing metrics and benchmarking reports.

         Resourcefully introduced data collection tools to improve source collection, reconciled central laboratory vendor data, and effectively resolved problematic data identified during review activities.

         Ensured all clinical trials conformed to SOPs, FDA regulations, and ICH/GCP guidelines.

         Drove QA operations by tracking clinical CAPAs and following up with stakeholders for swift remediation.

         Collaboratively structured remediation plans as required to resolve protocol deviations.

         Formally awarded and recognized for vision and values related to team-building, clinical data quality assurance, and clinical trials office development .

Bausch & Lomb, (Kelly Clinical Services), Rochester, NY, 2010 2011

Clinical Quality Specialist

         Delivered influential support to Global Clinical Operations department by reviewing, validating, and optimizing clinical QA for medical devices.

         Conducted gap analysis, performed comprehensive system and study GCP audits, and compiled audit reports featuring requests for CAPA to expedite and ensure compliance with SOPs and clinical quality plan schedule.

         Devised instructional materials for project team members and delivered training to clinical researchers.

         Boosted quality of operations by steering Trial Master File project which converted files to electronic format.

         Prepared project-specific documentation, administered trial distribution agreements and investigational packaging agreements, relabeled activities, and successfully delivered audit-ready clinical trial package.

Prior Background:

Research Coordinator, Hometown Urgent Care & Research

Treasury Analyst, Colgate Palmolive

Industrial Engineer, Coopers & Lybrand

Bachelor of Science, Industrial Engineering, New York Institute of Technology, New York, NY

Drug Development Process; CFR; ICH Guidelines; HIPAA (clinical studies); Study Initiation, Monitoring, and Closing; Good Clinical Practice; SOPs Monitoring Clinical Studies, Inc., achieved 100% on final exam

Cancer Clinical Trials Basics NIH

CFR 21 Part 312 & 812 Subpart C, D, G CFR 21 Part 11, 50

ExpertRating TQM Certification ● Project Management Certification

5S ● JIT ● Lean Six Sigma Black Belt (in progress)

Microsoft (Word, Excel, PowerPoint, and Access), C++, Oracle, CAD/CAM, COBOL, GPSS, MRP, SAS/STAT, SPSS, SAP, Reuters, Bloomberg, Hyperion, MediNous, OpenClinica 3.0, BioClinica CTMS, Centricity, TranSenda, HEDIS, MedDra, Documentum, SharePoint, DOS, ComplianceWire, HTML, Medidata RAVE, IVRS, eCRF, eDiary, AutoCAD, Kintana, GDMS, Maximo, CatsWeb

Regulatory Affairs Professional Society

International Society of Pharmaceutical Engineering

Society of Clinical Research Associates