Hello,
This is my direct-client opening for a *Sr. Data Management Consultant* for a 4-6 month contract. The position is located in *San Francisco**, CA**.* The Senior Data Manager Consultant (SDM) will be responsible for managing the outsourcing of clinical studies to several contract research organizations (CROs) and for the execution of the data management life cycle process (e.g. CRF design through Database Lock). The SDM will coordinate with the clinical operations team to ensure the accurate and complete data collection for our global oncology and cardiovascular programs. The consultant will be the key contact with the CRO for Data Management related issues or problems and will liaise with internal customers to manage and resolve Data Management issues. The SDM is responsible for ensuring that Data Management deliverables are met. *Responsibilities (included, but are not limited to) * Reviews, creates, and maintains the Data Management Plan throughout the life-cycle of the study protocol, which includes: CRF annotation, database specifications, edit checks, and other pertinent Data Management documents. Provides leadership to and coordinates with the data management staff at the CROs to ensure database lock and release of data for analyses. Spear heads agenda and meeting minutes from CROs deliverables. Monitors and tracks the quality of all data management deliverables ensuring audit practices have been enacted to validate the quality and assurance of database content from CROs as well as other external electronic data transfers. Reviews and reconciles Serious Adverse Events and Adverse Event data. Reviews coded adverse events and concomitant medication data. Reviews and generates patient profile listings for internal or external review, as well as laboratory data (e.g. Chemistry and Hematology) for discrepancies and communicates any outstanding issues, for CRO action and correction. Coordinates and ensures smooth SAS datasets or electronic load data transfers from CRO's. Reviews and understands study protocols and other clinical related materials. Actively participates in clinical sub-teams presenting Data Management concerns and issues. Interacts with Director of Biometrics, Manager of Clinical Data Management, Statisticians, Programmers, Clinical Trial Project Managers, Medical Monitor, and other personnel to provide support in the areas of data management. Provides input on existing or new SOPs and other procedural documents to maximize productivity and efficiency with the Biometrics department. Maintains an overall knowledge of regulatory guidelines, industry standards, and new technologies. Responsible for assigned studies or ongoing projects to ensure that work is proceeding in an efficient manner and that project' timelines are met. Communicates project status and key project issues to Manager of Clinical Data Management. Communicates back to clinical sub-team with post-mortem investigation of previous studies (e.g. lessons learned) for study design and continuous improvement of new studies. *Requirements: * Minimum of 5 to 7 years experience as a Senior Data Manager working within a pharmaceutical or CRO environment, with overall exposure from inception to conclusion in managing Phase I, II and III clinical studies. Minimum of 2 to 3 years managing external vendors for Data Management in a leadership capacity. Minimum 2 to 3 years proficiency in the use of clinical database or systems such as EDC, IVRS, Oracle Clinical(R), ClinTrial(R), and Integrated Review(R). Understanding of Clinical Data Interchange Standards Consortium (CDISC) and SAS(R) terminology. Therapeutic experience in oncology and cardiovascular is a must. Bachelors Degree or equivalent in life science, computer science, business or related discipline. Understanding of the coding process and terms in MedDRA, WHODRUG and CTCAE. Thorough knowledge of applicable regulatory rules and guidelines, including ICH group. Complex and/or international trials experience. *Please complete the following skills-matrix and send back with your updated resume. * Full Name: Degree/Major: Total Data Management Experience: Total Pharmaceutical/CRO Experience: Total Experience with clinical databases or systems such as EDC, IVRS, Oracle Clinical(R), ClinTrial(R), and Integrated Review: Total experience managing external vendors for Data Management: Do you have understanding of the coding process and terms in MedDRA, WHODRUG, and CTCAE? Hourly Rate: Whether is it C2C/1099/W2? Day Phone #: Evening Phone #: Cell Phone #: Availability: Current City/State: *Thanks & Regards*……… [image: Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet. Right-click here to download pictures. To help protect your privacy, Outlook prevented automatic download of this picture from the Internet.] *Pramod Dubey* * * *BeyondTek IT - "Think Human. Think Technology. Think Beyond." * *Phone (*:* *714-857-2010* Extn: *801 *Email ID ***:* [EMAIL PROTECTED] * *Yahoo IM: Pramod_Beyondtekit* *Linkedin*: *http://www.linkedin.com/in/pramodjohnmark* *Note:* We respect your Online Privacy. This is not an unsolicited mail.. This mail cannot be considered Spam as long as we include Contact information and a method to be removed from our mailing list. 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