Enthusiastic team player with 12 years of Clinical Trial experience seeking a position within Clinical Research and Development. Proven ability to manage multiple fast-paced, high profile clinical studies; experienced with Phases 1, 2 and 3, including study start-up, execution and close-out. Knowledgeable in several clinical trial systems as well as ICH GCPs, SOPs and confidentiality. Excellent attention to detail and quick to learn new technologies and processes.
19 years of pharmaceutical experience (Clinical Trials Associate, Clinical Editor, Clinical Study Manager, Project Coordinator, Regulatory Report Coordinator, Clinical Data Associate and Associate Scientist). Successfully maintained compliance of ICH GCP guidelines and client SOPs while completing high quality project deliverables. Developed effective and productive partnerships with internal and external teams and team members ensuring deliverables met project deadlines, goals and objectives. Produced high quality, compliant "Submission Ready" clinical documents for regulatory agency filing. Extensive experience with editing, formatting, and proofreading various types of clinical documents for accuracy, clarity, consistency, punctuation, spelling, grammar, medical terminology and scientific accuracy. Ensured clinical documents were compliant with regulatory guidelines, ICH guidelines, AMA style guidelines, as well as various corporate guidelines (SOPs, REGs, Global Rulebook, and Global Style Guide).
Highly organized, detail-oriented individual, with a broad background and expertise with GxPs, provide quality work and excellent customer service while maintaining positive communication with professionals on all levels. Have more than 30 years’ experience in the pharmaceutical industry with an extensive professional background in Clinical Operations as Clinical Trial Manager with GCPs, as well as QA Document Control Team Leader in Change Control, CAPAs, Deviations and 13 years as a laboratory scientist in the drug product release/ stability laboratory in GMP environments. Understanding of FDA 21 CFR 58 Good Laboratory Practice regulations, 21 CFR Part 11 Electronic Signature; Electronic Records, and data integrity requirements.
Sound judgment in confidential materials and projects; organized and collaborative team player; self-directed, works effectively with study teams and also works effectively independently with minimal supervision; adeptly handle electronic file databases as well as handle paper documentation for Clinical Trials as required to maintain regulatory compliance; proficient use of Microsoft Office; ability to easily learn and adept to new software programs.
Vast expertise as Trial Master File Specialist, Clinical Document Specialist processing documents utilizing 2017 Starting Point Templates, Standard Operating Procedures Manager (SOP) for Medical/ Regulatory Affairs implementing SOPs using Documentum; Collaborate with internal and Contract Research Organizations (CRO) study management teams to ensure the conduct of clinical trials in compliance with Code of Federal Regulations (CFR)/International Conference of Harmonization Practice (ICH) and Good Clinical Practice (GCP) guidelines and Sponsor and CRO SOPs regulations.