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Subject: Clinical Data Analyst Location: Cambridge, MA Duration: 6-12 months contract Note: Need G.C-EAD,G.C & U.S Citizen *Reply Me At j...@itbtalent.com <j...@itbtalent.com>* Contact till end of the year with potential extension -3+ years experience in Clinical Data Management or comparable position in Pharmaceutical/Biotech industry (Sponsor, CRO or combination). -Bachelor’s degree required. Master’s degree preferred. -TOP 3 CRITERIA -The Sr. Clinical Data Analyst should perform oversight activities to Contract Research Organizations (CROs) in support of clinical data management project activities according to Standard Operation Procedures. Ensure adequate oversight to outsourced activities by performing quality control steps. 1. Develop user acceptance testing (UAT) plans and perform risk based review of clinical data for electronic data capture systems. 2.Must be a solid team player, able to meet deadlines and handle changing priorities. Ability to work on a multidisciplinary team and to prioritize activities. Clinical Data Analyst Baxalta Incorporated (NYSE: BXLT) is a $6 billion global biopharmaceutical leader developing, manufacturing and commercializing therapies for rare and chronic conditions in hematology, oncology and immunology. Driven by passion to make a meaningful impact on patients’ lives, Baxaltas broad and diverse pipeline includes biologics with novel mechanisms and advanced technology platforms such as gene therapy. The Baxalta Global Innovation and R&D Center is located in Cambridge, Massachusetts. Launched in 2015 following separation from Baxter International, Baxaltas heritage in biopharmaceuticals spans decades. Baxaltas therapies are available in more than 100 countries and it has advanced biological manufacturing operations across 12 facilities, including state-of-the-art recombinant production and plasma fractionation. Headquartered in Northern Illinois, Baxalta employs 16,000 employees worldwide. The Sr. Clinical Data Analyst should perform oversight activities to Contract Research Organizations (CROs) in support of clinical data management project activities according to Standard Operation Procedures. Ensure adequate oversight to outsourced activities by performing quality control steps. Key Responsibilities: ? Provide input to and review of Data Management Plans in support of clinical study deliverables. ? Contribute to and provide oversight of the design, creation and lifecycle management of data collection, validation and reporting, including: -Case Report Form design and setup -Preparation and execution of database extracts/lock activities. -Review and verification of study data for completeness, consistency and plausibility via spot checks. -Development of test plans and performance of risk based user acceptance testing for study data capture systems. ? Review documentation for accuracy and compliance to procedures. Obtain resolution on areas identified as nonconformant. ? Participation in project team meetings and partnering with Clinical Operations, Biostatistics and Therapeutic Areas to effectively manage project related issues. ? Create submission packages of study data and perform relevant quality control steps. ? Identification and escalation of project specific data handling and data management issues. ? Final archiving of project documentation and databases. ? Function as a backup to the Clinical Data Project Manager on all project related activities. Sr. Clinical Data Analyst Req. 5001KX Requirements: ? Understanding of regulatory requirements and guidelines ? Understanding of and experience with all activities supporting a Clinical Trial from Data Managements perspective ? (from protocol review to e-submission). ? Strong analytical, organizational and excellent communication skills (both verbal and written). ? Must be a solid team player, able to meet deadlines and handle changing priorities. Ability to work on a multidisciplinary team and to prioritize activities. ? Medium level of technical understanding and proficiency in use of standard software and motivation to explore new tools ? Knowledge of relational database concepts. ? Proficient problem solving and analytic skills (project management experiences) ? Working in a CRO environment and understanding the concepts of provider oversight in a virtual team environment across diverse cultures. Regards, Jack Anderson -Sr.Technical IT Recruiter ITBrainiac Inc., j...@itbtalent.com Direct : 609-935-3773 X 103 116 Village Blvd, Suite 200 - Princeton, NJ 08540 www.itbrainiac.com -- You received this message because you are subscribed to the Google Groups "SAP BASIS" group. To unsubscribe from this group and stop receiving emails from it, send an email to sap-basis+unsubscr...@googlegroups.com. To post to this group, send email to sap-basis@googlegroups.com. Visit this group at https://groups.google.com/group/sap-basis. For more options, visit https://groups.google.com/d/optout.
