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Online Resumes with "CTMS"

Clinical Research - 15 Years of Experience

Tags for this Online Resume: gcp, ich, oncology, clinical, protocol, CTMS, EDC

Clinical Research - 20 Years of Experience - Near 27712

QUALIFICATIONS SUMMARY Study Manager and Clinical Development Scientist with 10 years extensive pharmaceutical industry experience managing Phase II - IV clinical research studies. Additionally, over 7 years as a Clinical Research Associate/Scientist (2 years were as a Sr. Clinical Research Scientist). The majority of those 17 years were in Phase II through IV CNS. Prior to the pharmaceutical industry I have 11 years in Cli...

Tags for this Online Resume: Project Management, Project Manager, Clinical Research, Research, Management, Monitoring, Protocol, Query, Acceptance Testing, Advertising, clinical, protocol, trial, phase

Clinical Research - 20 Years of Experience - Near 27518

A detail oriented, dependable and organized Clinical Trials/Research SME in pursuit of a position with progressive responsibilities, in a customer driven team oriented organization, which allows the maximum use of my technical and administrative skills and abilities.

Tags for this Online Resume: North Carolina, ICH/GCP Certified , Publishing, PowerPoint, CTMS, Core Clinical Research Training , Organizational and office management skills, Notary, Management, Documentation

Regional Home-Based CRA

Tags for this Online Resume: oncology, phase, clinical, trial, gcp, protocol, pharmaceutical, Cardiovascular, CRO, Neurology, Bone, immunotherapy, monitoring, Initiation, close-out, Remote, query, onsite, SOP, ICH, GCP, investigator, IRB, sponsor, CTMS, CNS, Endocrinology, Haematology, ICF, Informed Consent, EDC, SDV, InFORM, MediData Rave, eTrial, eDiary, MedWatch, Adverse Event AE, SAE, 1572 Statement of Investigator, IB, Trip Report

Clinical Regional Monitoring

Accomplishments: * Compliance- Maintained compliance with regulatory standards. Ensuring site staff was trained and followed all guidelines set forth by the FDA. * Implementation-Implemented a new tracking system that resulted in improved query resolution. * Documentation-Ensured study sites followed ALCOA to ensure accuracy of through precise documentation. * Patient Safety-Ensured quality control through following ICH/GCP...

Tags for this Online Resume: Audit, Compliance, Data Quality, Documentation, Forth Programing Language, Good Clinical Practices, ICH, Management, Monitoring, Protocol

Clinical Regulatory Affairs - 6 Years of Experience - Near 92648

QUALIFICATIONS Document-Labeling Specialist, Nov.2015 - Feb.2016 Well-versed communicator, high organizational and analytical (Contract Position Only) abilities. Work well independently and as a member of a * Creation, Revision of CGL, pre-printed labels and IFU via team. Adept in SUSARs, IRB submissions, Sponsor redlining documents and SOP standards. monitoring, and CTMS files. Efficient at handling multiple regulatory doc...

Tags for this Online Resume: R programming, Word, Excel, Adobe Photoshop, Illustrator, google analytics, github, Adobe, Data Entry, Documentation, ISO

Clinical Research - 20 Years of Experience - Near 32828

My career objective is to become a part of your Organization and to apply my experience and knowledge during the conduct of clinical trials, with emphasis on safety, efficacy in accordance to ICH-GCP, FDA and study protocol guidelines. Further, I will always strive to accomplish efficiency and savings for clients, by developing effective monitoring tools

Tags for this Online Resume: Microsoft-Office, ICH-GCP, FDA-guidelines, CTMS, EDC, RAVE, Monitoring, Clinical trials, Cardiovascular, Management, Auditing


Highlights of Qualifications Multiple years of experience in community outreach engaged in environmental conservation project management and implementation. High level of performance in ability to work both collaboratively and independently with strong interpersonal skills extremely detailed orientated extensive problem solving management of data entry excellent communication skills and ability to interpret complex informat...

Tags for this Online Resume: Cardiopulmonary resuscitation (CPR), Communication Skills, Data Entry, Dec, Distribution, English Language, Excellent Communication Skills, Management, Mergers, Problem Solving

Featured Profile

Sr. Clinical Research Associate - 22 years Experience - remote - Austin, TX

A top-performing Senior Clinical Research Associate with extensive experience in clinical research, GCP, ICH, Regulatory, and clinical site management/monitoring. Solid background in critical care nursing for in-depth understanding of medical terminology for records review. Highly skilled in spearheading internal teams through clinical research and document management to ensure accuracy and adherence with study specific str...

Ideal Companies: Pharmaceutical, Biotech, Medical Device, CRO

Tags for this Online Resume: Clinical Research, Management, Protocol, Research, Documentation, Medical, Allergy, Monitoring, Reporting Tools, Cardiology, clinical, trial, gcp, protocol, pharmaceutical, regulatory, medical device, CNS, EDC, contract, remote, CRO

Featured Profile

Pharmaceutical CMC Development | cGMP Manufacturing | Product Quality

Senior manager and director of pharmaceutical process chemistry, manufacturing and controls (CMC) specializing in cGMP, quality and regulatory compliance of novel small and large molecule therapeutic drugs including peptides, nucleotides, protein biologics and antibody drug conjugates (ADCs). Skilled in technology transfer, analytical method development and validation, quality risk assessment, deviation management, investi...

Ideal Companies: Shire, Biogen, Lonza, Genzyme, Sarepta.

Tags for this Online Resume: Chemical Process Development, API, cGMP Manufacture, Technology Transfer, Management, Quality, Risk Assessment, Pharmaceutical Operations, FDA and ICH Drug Regulations, CRO, CDMO and CMO Oversight, CMC Process Chemistry, TrackWise QMS, Change Controls, Deviation Management, Investigations, Root Cause Analysis, CAPA, Antibody Drug Conjugates, IND, IMPD, NDA, MAA and BLA

Clinical Data Management - 3 Years of Experience - Near 08872

Tags for this Online Resume: Business Operations, Data Entry, Protocol, Training, Administrative Assistant, Oncology, Regulatory Affairs, Research, Data Quality, Quality

Not Listed - 0 Years of Experience

3-years' experience coordinating and assisting in clinical trials monitoring activities * Sound knowledge of Good Clinical Practices (ICH-GCP) and FDA regulations * Vast experience in billing and coding, data management, data entry, conducting billing practices, and other administrative tasks * Familiar with various computerized coding programs and electronic health records. * Advanced medical/scientific knowledge and medi...

Tags for this Online Resume: Insurance, Audit, Compliance, Clinical Research, Data Management, Documentation, Filing, Management, Monitoring, Research