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Please Respond to [email protected] Title: IT Project Manager with Pharma Clinical Development Exp (2 to 4 positions) Duration: 6 months contract Location: East Hanover, NJ** *Description:* The Oracle System Life Science Hub (LSH)Ramp Up Role is a LSH Generalist Role (covering the scope of the LSH Administrator, LSH Standards Officer, LSH Security Officer, LSH Specialist and LSH Quality Manager) created to initially operate LSH for the Early Adopter Trials. The role owners will be trained and contribute to the CAIRO project work prior to operationally execute the Early Adopter trials from March 2010 onwards. *In particular, the tasks of the LSH Ramp Up Role comprise:* Participation in Oracle LSH Training Familiarization with CAIRO Business Processes Introduction to ADVANCE, i.e. ADVANCE End to End Process, iMDR / MDR, SCR, CDMS, J-Review Participation in other relevant Training based upon individual need Contribution to CAIRO Release 2 UAT execution Prepare LSH training materials based upon available SOP/BG documentation Contribution to LSH Operations Organization Ramp Up activities the LSH Ramp Up Roles are foreseen to operationally execute the CAIRO Release 2 processes for the Early Adopter trials (covering the scope of the LSH Administrator, LSH Standards Officer, LSH Security Officer, LSH Specialist and LSH Quality Manager). Besides that, the role owners might be requested to contribute to the LSH-CD project and CAIRO Releases 2.1 and 3. In particular, the tasks of the LSH Ramp Up Role from Feb/Mar 2010 onwards comprise: Creation and maintenance of new studies in LSH Provision of user access to defined data sets for Novartis internal and external parties, e.g. CRO’s For studies in scope initiate and manage data load from external sources into LSH For trials in scope manage conformance of data load sets into NCDS format For assigned clinical trials manage blinding and unblinding data process in LSH For studies assigned to other LSH Specialists, validate newly created/changed studies, study templates, conforming table lists, user groups, and meta data from GPS II For trials associated to other LSH Specialists, evaluate requests for update security design specification, template/object design specification and classification design specification For studies assigned to other LSH Specialists, implement role/subtype changes and classification hierarchy updates Contribute to LSH Operations Organization ramp up, i.e. provide feedback to processes, suggest process and functionality improvements, provide input into effort estimations and role descriptions *Skills:* *Working experience: * Min. 2-3 yrs working experience in Pharma Clinical Development, ideallly in preparing and maintaining clinical databases *Skills and knowledge: * *Technology skills: * *Oracle LSH, PL/SQL, SAS *(mid term) Functional knowledge and skills: Experience in Data Mapping Knowledge of *Clinical Data Models / CDSIC / NCDS / NOV DD * Overview of ADVANCE End to End Process, *iMDR / MDR, SCR, CDMS, J-Review* *Soft skills: * Analytical Skills Problem Solving Skills Initiative Accountability Results Orientation Communication Skills Sincerely, Jay || Phone: 916 646 2080 Ext 215 || Fax: 916 646 2081 || Email:[email protected] <email%[email protected]> || Website: www.key-soft.com || Note: This email is not intended to be a solicitation. Please accept our apologies and reply in the subject heading with REMOVE to be removed from our mailing list. -- Introduce business in 3800 cities. How? ===================================================== Thanks for using group. Moderator 1) This group is managed by www.BRCIndex.blogspot.com 2) Post your message with your linkedin Profile (Visit linkedin.com) to confirm your identity and refer business. 3) Visit www.BRCIndex.blogspot.com (3800 Business Referral Club) 4) Reply to two message before posting new one. 5) Donot post same message in all 3800 business Referral Club. You received this message because you are subscribed to the Google Groups "Outsource" 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/Outsource
