Updated: 5/25/2012
Clinical Data Management Systems Manager - Electronic Data Capture (EDC) OperationsThis role may be based at Amgen's corporate headquarters in Thousand Oaks, California, or at Amgen's South San Francisco site.
The CDM Systems Mgr - EDC Operations is the technical Subject Matter Expert and point-of-contact to ensure electronic clinical data management operations of Amgen's 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.
The 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.
Basic Qualifications
Doctorate degree
OR
Master's degree & 3 years of directly related experience
OR
Bachelor's degree & 5 years of directly related experience
OR
Associate's degree & 10 years of directly related experience
OR
High school diploma / GED & 12 years of directly related experience
Preferred Qualifications
• 3+ or more years of experience in a technical role within clinical data management, clinical development, or IS/IT
• Effective partnering and client management skills creating productive engagement capabilities to meet stakeholders and clinical study teams requirements
• Experience successfully implementing and operating clinical data management collections systems specifically EDC platforms such as Medidata Rave and/or Oracle InForm
• Medidata Rave, Oracle InForm hands-on operational and system knowledge desirable
• Work experience integrating other clinical technologies including but not limited to IVRS, CTMS, ePRO or other related technology in the pharmaceutical/biotechnology industry preferred
• Experience and ability creating and effectively presenting concepts and materials to senior and executive levels
• Knowledgeable in Good Clinical Practices, and Global Regulatory regulations as necessary
• Knowledge of ITIL v3 and basic Industry IS best practices
• Candidates should demonstrate project management and technical expertise, attention to detail, and excellent documentation and communication skills
• Excellent time management and organization skills required
• Must have sound problem resolution, judgment, and decision-making abilities
• Must be able to work well in a global team-based matrix environment with minimal supervision
• Working knowledge of industry standards such as CDISC, SDTM, CDASH, HL7 and other standards initiatives desirable
• 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.
The 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's 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.
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