[{"country_short": "USA", "city": "South San Francisco", "description": "Auto req 12764BR\nJob Posting Title Clinical Data Management Systems Manager - Electronic Data Capture (EDC) Operations\nCareer Category Clinical Development\nEmployee Subgroup Salaried FT\nCountry (State/Region) United States - California\nLocation (City) South San Francisco\nThousand Oaks\nAmgen Job Description This role may be based at Amgen's corporate headquarters in Thousand Oaks, California, or at Amgen's South San Francisco site.\n\nThe CDM Systems Mgr \u2013 EDC Operations is the technical Subject Matter Expert and point-of-contact to ensure electronic clinical data management operations of Amgen\u2019s global Electronic Data Capture Operations service. The manager will have operational responsibility for delivery of electronic data collection systems such as Medidata Rave and Oracle InForm. These responsibilities include the delivery of EDC system capabilities, design and implementation of key system integrations, and the development of system-related EDC best practices.\n\nThe position is expected to partner effectively with other CDM Systems staff to seamlessly ensure high quality deliverables such as EDC platform upgrades, EDC architecture design, integrations with internal and external clinical systems, custom report programming, and other clinical data management activities related to the use electronic data capture technology. Through active service management of service providers the manager is responsible for representing Amgen in supporting the Operational Management Team and Functional Management Team governance bodies in partnership with Amgen Global Supplier Services, ensuring quality service delivery and supplier performance.\nBasic Qualifications Doctorate degree\nOR\nMaster\u2019s degree & 3 years of directly related experience\nOR\nBachelor\u2019s degree & 5 years of directly related experience\nOR\nAssociate\u2019s degree & 10 years of directly related experience\nOR\nHigh school diploma / GED & 12 years of directly related experience\nPreferred Qualifications \u2022 3+ or more years of experience in a technical role within clinical data management, clinical development, or IS/IT\n\u2022 Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements\n\u2022 Experience successfully implementing and operating clinical data management collections systems specifically EDC platforms such as Medidata Rave and/or Oracle InForm\n\u2022 Medidata Rave, Oracle InForm hands-on operational and system knowledge desirable\n\u2022 Work experience integrating other clinical technologies including but not limited to IVRS, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred\n\u2022 Experience and ability creating and effectively presenting concepts and materials to senior and executive levels\n\u2022 Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary\n\u2022 Knowledge of ITIL v3 and basic Industry IS best practices\n\u2022 Candidates should demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills\n\u2022 Excellent time management and organization skills required\n\u2022 Must have sound problem resolution, judgment, and decision-making abilities\n\u2022 Must be able to work well in a global team-based matrix environment with minimal supervision\n\u2022 Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable\n\u2022 Leadership Skills : The manager, EDC Operations will be a highly motivated, decisive and results-oriented individual with the flexibility and creativity to excel in a multi-project, high-pressure environment. The manager will have extensive clinical trial technical experience and leadership expertise. He or she will have substantial technical background to deliver the EDC operations associated with the Amgen portfolio. With strong negotiation skills, he or she will be able to address conflict head-on and facilitate rapid resolution to issues.\n\nThe ideal candidate has a proven track record and experience in either working in and/or leading a technical team. The candidate must be able to represent Amgen\u2019s business requirements and needs by effective partnering and working with outsourced service delivery partners such as an FSP, ensure operational experience with clinical database management systems (preferably Medidata Rave and Oracle InForm) and have strong communication skills to maintain a high level of transparency between CDM systems centers of excellence, clinical study team members, CDM business units, and other stakeholders.", "date_new": "2011-11-28 21:31:18", "url": "http://www.amgen.jobs/xml/25067023/job", "country": "United States", "company": "Amgen", "title": "Clinical Data Management Systems Manager - Electronic Data Capture (EDC) Operations", "reqid": "12764BR", "state": "California", "state_short": "CA", "location": "South San Francisco, CA", "uid": 25067023}]