Posts Tagged clinical studies

JOBS – November, 2012


For the opportunities below, please send resume to wd_darshana at hotmail dot com. Candidates must be based in the USA and have valid US work visa.  More opportunities will be added soon.

Clinical Data Manager – Redwood City, CA

There is an immediate opening for Clinical Data Manager for San Carlos, CA based medical device company. Responsibilities include, design, develop and enhance clinical databases and data reports and perform validation of databases and reports to ensure data accuracy, completeness and integrity of data entry, discrepancy database management, study documentation and data auditing. Job functions include, participating and providing support for data management activities, investigator meetings, DSMB meetings and regulatory submissions, assisting study team with the preparation of data collection forms and charts for the reporting of research data, supporting international and FDA regulations and company goals, policies and procedures, and complying with Quality System.

Requirements include, knowledge in regulatory requirements, FDA, ICH, GCP etc. guidance, experience using Commercial Off the Shelf Clinical Data Management and/or Electronic Data Capture products (e.g. Clindex, Oracle Clinical, Phase Forward, eTrials, etc.) is required. Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) is a plus. Also required, a Bachelor’s degree in related field with minimum 3 years experience in clinical data management supporting clinical trials, including experience in regulatory submission of drugs or medical devices (510K, class III devices, PMA).

Sales Rep Opportunity – Orange County, Los Angeles, CA

This position will play a visible role in drug rep industry, by developing critical relationships, primarily with doctors of many disciplines to share the availability of breakthrough pharmaceutical grade pain management option that would diminish pain, aid in sleep, and enhance quality of life as a holistic alternative to addictive and sometimes life threatening drugs. Specific responsibilities will include, provide field based scientific exchange and communication regarding the product, broad interdisciplinary background and proven ability to establish relationships with doctors across variety of disciplines, tenacity and drive to reach out to new doctors, and ability to work the referrals, and to network and partner with medical practitioners. Requirements include, pharma or medical industry sales background, strong sales success track record, consummate professionalism including understanding of sensitivity of subject along with ability to deal warmly with high powered, industry-leading medical professionals, strong entrepreneurial spirit and passion for the vision of managing pain with a holistic alternative. Compensation will include commission, bonuses, and stock options during the first 60 days and then will include cash based compensation. This position is located in Los Angeles, Orange County, CA.

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FDA Guidance on Clinical Data Standards


Thamar Draper, a 20 year pharma industry veteran with expertise in project management, clinical software implementation and training, and Senior Director of Professional Services at Omnicomm (www.omnicomm.com), talked about FDA guidance on clinical data standards at http://www.bio2devicegroup.org .

The current new draft of FDA Guidance on Standardized Study Data was released February 2012. The actual guidance is expected to come in 2013, NDAs are expected to conform by 2015, and INDs are expected to conform by 2016. This guidance establishes FDA’s recommendation that sponsors and applicants submit study data in a standardized electronic format. The guidance guidelines apply to collecting the data in electronic format and to standardization of data itself. Also when moving data around or integrating systems, it should be standardized and validated. Sponsors should consider during planning phase of study which data standards are applicable. Conversion of data to a standardized format at a later date reveals errors that could have been fixed earlier. Therefore, conversion of non standardized data to standardized format at a later date, is discouraged. For clinical and non clinical studies, sponsors should describe in the IND, their plan to submit standardized study data. Draper is a subject matter expert in the areas of EDC systems, clinical data bases and clinical data standards and is actively involved with CDSIC, a global, open, multidisciplinary, non-profit organization that has helped establish these standards to support the acquisition, exchange, submission and archive of clinical research data and metadata.

FDA uses certain review tools to review data and they want to review data in the same software. All data collected in the study are required to be submitted. Data validation is required and includes guidance on identifying issues early in data process and use manual inspection for data deficiencies. Technical validation guidance pertains to edit checks to validate the data and Business validation guidance pertains to supporting the data with meaningful analysis and finding errors in the data.

Draper then discussed Omnicomm’s Electronic Data Capture (EDC) and eClinical technologies with standards for Library, Data Collection, Data Exports, and Data Analysis, that can effectively and efficiently help companies comply with FDA guidance while also expediting clinical decisions and submissions. The talk was followed by Q&A.

 

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