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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. *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: * If you qualify for this position, are available immediately and are interested, please send your resume, rate and contact information to * mailto:[EMAIL PROTECTED] <[EMAIL PROTECTED]> Sr. Data Management Consultant - San Francisco, CA* * Please ensure you complete and copy/paste the above-completed matrix with your response *Thanks * *Guna* BeyondTekIT Placentia, CA [EMAIL PROTECTED] *Ph: 714 857 2002 extn 818* *Fax: 714 364 9705* *IM: **guna_beyondtekit* --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "Oracle-Distribution" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [EMAIL PROTECTED] For more options, visit this group at http://groups.google.com/group/Oracle-Distribution -~----------~----~----~----~------~----~------~--~---
