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Online Resumes with "Trial Master File"
Seeking for a challenging career in a progressive organization offering the opportunity for contributing my skills services to the organization and personal growth and to work sincerely with maximum effort using best talents and with a challenge to achieve required goals and targets, abiding to the decisions of seniors and to earn a good reputation what ever required.
Tags for this Online Resume: Develop, maintain and manage appropriate study documentation, Developing, writing and presenting the clinical trial protocols, Initiate, maintain and reconcile Trial Master File., Monitoring the trial throughout its duration which will involve visiting the Study centers on a regular basis to check the patient data in the case report forms (CRFs) and to sort out any problems which may arise., Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other Data collection tools by careful source document review Monitor data for missing of implausible data., Complete Serious Adverse Event (SAE) reporting, process production of Reports, narratives and follow up of SAEs and managing the clinical data intermilitently as per 21CFR USFDA guidelines, Monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines., Independently perform CRF review; query generation and resolution against established data review guidelines on client data management systems as assigned Perform other duties as assigned by management., , maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
Worked s a clinical research assistant for 5 years, creating clinical documents, preparing central files,edc data entry and verification, inventory management. Lab instruments calibration, operation and maintenance. 8 years of experience as a QA technician
Established reputation as a highly motivated and productive professional in the CRO/Pharmaceutical/Biotechnology industry. Able to quickly and thoroughly gain expertise in a particular field and integrate new information with the existing knowledge. Capable of identifying and solving complex problems in creative and logical ways. Adept at combining critical solutions with imagination, innovation, and a sense of humor. ...
I am a Document Quality Coordinator/Clinical Trial Assistant with 3 years experience with pharmaceuticals and 3 years with CROs. My expertise in with organizing, maintaining, and quaity checking Investigator files and General files, hard copies and electronic documentation. I keep track of updates on essential documents from sites - IRB approvals, CVs, Medical licenses, and Financial disclosures,protocol, IB, study manual ...
Experienced Clinical Research Professional interested in positions within the pharmaceutical or medical device industry.
Two years’ experience with clinical responsibilities for medical device companies with Class II devices – including an in-vitro molecular diagnostics device to detect infectious disease and a dermatological radiofrequency device that ablates nerves to reduce forehead wrinkles. Qualifications include leading a recruitment effort to secure 65 patients in 3 months across 5 sites, experience conducting and monitoring GCP phase ...
SUMMARY Self-motivated, dedicated and hardworking professional with greater than 30 years of experience in Clinical Operations (Clinical Associate, Trial Master File, Grants & Payments) and Clinical Development & Medical Affairs within the pharmaceutical industry. Major strengths include excellent communication and organizational skills. CORE STRENGTHS Knowledge in Clinical Trials and Drug Development for Clinical Developme...
Tags for this Online Resume: Clinical Trial Associate, Immunology, Clinical Operations, Medical, Medical Affairs, Oncology, C Programming Language, Cardiovascular, Database, Hepatitis, clinical, phase, oncology, trial, protocol, gcp, pharmaceutical, ich, TMF, Clinical Payments, sap
Summary Clinical Scientist/Clinical Data Analyst/Clinical Data Management/Project Coordinator/GLP auditor/Research Biologist with over 15 years experience in the pharmaceutical industry. Authored/QC review of protocols, protocol amendments, protocol clarification letters, informed consent forms, risk language, periodic safety reports (PSUR, DSUR, QSR), investigator brochures, medical monitoring plans, clinical SAE narrative...
SUMMARY * Project coordination, document management and coordination experience in a clinical health environment in pharmaceutical industry. Worked for Spark Therapeutics, Baxter, Execupharm, United BioSource (an Express script company) and Liquent (a Parexel Company) * 3 + years of experience in Regulatory Affairs supporting the compilation of regulatory submission and assisting with the publication those submissions using...