Hi, Greetings from E-Solutions Inc.!!
Hope you are doing well. This is *Alok *from* E-Solutions Inc.* Trying to reach you in reference to the below job position. Please share your *updated resume* and *expected rate* with me. Feel free to contact me at *408-827-9435* <(408)%20827-9435> for more information. *Need Passport Number in case of H1B and Any EAD* *Position:* *Document Management Specialist* *Location: Rochester, NY* *Job Description:* · The DM specialist will be involved in most activities like in preparation for study set up, conduct and completing a Clinical Trial which usually includes: · Manage documentation associated with clinical trials, both in paper and electronic format, including transitions and conversions. · Follow records management tasks, policies and procedures protecting record integrity by ensuring full compliance to GCP principles and client SOPs. · Perform audit and quality control checks on paper based studies and Electronic Data Capture systems. · Experience in using electronic document management system, including QC approval of workflows and uploading · Receive, process and track all clinical project related paper and electronic documents including global study and site documents · Create and maintain filing structure for all the regulatory INDs, NDAs, CTAs, DMFs and SBAs · Fulfill company-wide requests for documents, records, and study reports; Liaise with study teams to coordinate the flow of trial documentation to the Records Center · Support project teams and functions in the preparatory activities for sponsor audits and regulatory inspections. · Conduct and manage electronic Trial Master File (eTMF) processes and train staff and deliver presentations regarding eTMF policies and procedures to disseminate knowledge and increase compliance. · Maintain logs and indexes to ensure information status is audit ready at all times and assist in the collection of data. · Manage and oversee the external archiving providers, including tracking of documents between Client and the external archive. · Experience and Skills Required: · Understand clinical trial processes and needs. · Experience – 4-6 years · Excellent organizational skills and time management. · Good attention to detail . · Work under pressure and to deadlines. · Pro- active, flexible and able to multi-task. · Self-motivation. · Work in a team and independently. · Excellent communication and influencing skills. · IT literacy, particularly in Word, Excel and PowerPoint · Education and Experience Background: · University degree or equivalent in health sciences, nursing or pharmacy or related field. · Previous experience of working in Clinical Research or the Pharmaceutical Industry. · Knowledge of the Industry/Clinical trial process and drug development. · Knowledge of ICH GCP and Trial Master File. *Best Regards* *Alok Sharma* 2 N. Market St., #400, San Jose, CA, 95113 Ph: 408.827.9435 | [email protected] |LinkedIn: https://www.linkedin.com/in/alok-sharma-2522474b www.e-solutionsinc.com Under Bill s.1618 Title III passed by the 105th U.S. Congress this mail cannot be considered spam as long as we include contact information and a remove link for removal from our mailing list. To be removed from our mailing list reply with "remove" and include your "original email address/addresses" in the subject heading. Include complete addresses and/or domain to be removed. We will immediately update it accordingly. We apologize for the inconvenience if any caused. If you have erroneously received this message, please delete it immediately and notify the sender. Before opening any attachments please check them for viruses and defects. WARNING: Computer viruses can be transmitted via email. The recipient should check this email and any attachments for the presence of viruses. The company accepts no liability for any damage caused by any virus transmitted by this email. -- You received this message because you are subscribed to the Google Groups "US_IT.Groups" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at https://groups.google.com/group/us_itgroups. For more options, visit https://groups.google.com/d/optout.
