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Online Resumes with "ICH Guidelines"
Exacting, highly organized researcher with more than 12 years of combined experience in the pharmaceutical industry and university-based clinical pharmacology settings. Experienced in investigation of Mechanism of Action of novel immunobiologics in investigator-initiated and clinical studies using disease-related biomarker selection and analyses. Strong background in designing and conducting studies pertaining to the ...
Ideal Companies: Biotech companies
Seasoned Clinical Research Professional with 10+ years experience in Clinical Research, including, CRA, Lead CRA, and Project Management duties. THerapeutic areas include oncology, endocrine/metabolism, and CNS.
A visionary, dynamic and effective technical leader with a proven track record of scientific vision, innovation and accomplishment to lead and manage R&D and Engineering teams. Excellent problem-solving skills combined with strong organizational, communication and interpersonal qualities to effectively function across multidisciplinary teams. Highly proactive, results and performance driven to meet and exceed business goals...
Have the experience and the knowledge of the clinical trial processes (start-up through close-out), including FDA regulations
Social/Clinical Trials Research Assistant/Coordinator/Clinical Support Specialist
Tags for this Online Resume: ICH Guidelines, IND Application, Guidance on HIPAA Privacy in Research, Protocol Amendment, Quality Assurance (QA), Serious Adverse Events (SAE) or Serious Adverse Drug Reaction (serious ADR), Source Document, Randomization
Accomplished Regulatory Analyst with expertise in all stages of drug lifecycle management and experience in strategy implementation and submission management, eager to contribute to the success of a progressive organization. Proven success in achieving and exceeding company goals and objectives in all aspects of day-to-day regulatory affairs and quality assurance initiatives. Adept at recognizing and analyzing several the...
Supply Chain Prifessional, who is analytical, resourceful and results oriented.
Ideal Companies: Procter & Gamble Inc., Pfizer Canada, Petro-Canada, Cabadian Superior, Magna Corp., Abbott Canada, Federal Express Canada , Siemens, Shell, BHP Biliton, GlaxoSmithKline Inc., Eli Lily
Can undertake most of the tasks and works independently. Very much focussed on the timelines and quite goal tending. Willing to help others in their prioritized tasks. Excellent planning, design and implementation. Highly experienced in writing reports and data analyses.
Clinical Supply Operation, Edison, NJ - 8+ Years of experience in pharmaceutical R&D, Clinical supply operations. Knowledge and experience in GMP, GCP and FDA/ICH guidelines. Good experience of computer programming and use of MS Suite of Applications, Dat
To find a challenging position as a manager for a growth-oriented organization, which offers diverse job responsibility and possibility for advancement.
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: ο Develop, maintain and manage appropriate study documentation, ο Developing, writing and presenting the clinical trial protocols, ο Initiate, maintain and reconcile Trial Master File., ο 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., ο 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., ο 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, ο Monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines., ο 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
Proven expertise in managing teams, streamline project paths encompassing an understanding of scientific data, analysis and interpretation of results, clinical developability and commercial viability of projects.
Senior/ Lead Clinical Reseach Associate - over 15 years experience monitoring, site management, medical record review, training/mentoring junior CRAs. database locks. regional clinical team leader
My goal is to secure a regional, home-based position in which I can use my knowledge of all phases of clinical research to develop tools to collect data (CRFs/edit checks; to verify the data (site management/monitoring), clean data (database locks)and to insure patient safety by assuring all AE/SAEs are reported, protcols and infomed consent are IRBs approved and adherence to all ICH guidelines and regulations.